StudyFinder
Search Results Within Category "Heart Health"
Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
Search all categories
23 Study Matches
SynCardia 70cc TAH-t for Destination Therapy (DT) (RA-540)
Judy Skroback, CIP, CRCP - jskroback@syncardia.com
Medalion, Benjamin
NCT02232659
HM20004553
Show full eligibility criteria
Hide eligibility criteria
Primary Arm
• Patients with ife-threatening, irreversible biventricular heart failure (Intermacs Patient Profile Classifications 1 - 4)
• Ineligible for cardiac transplantation (e.g., contraindication to immunosuppression, cancer, elevated panel reactive antibodies [PRAs]) as determined by the implanting center at time of implant screening assessment.
• On optimal medical management and failing to respond or failing DT VAD therapy (continuing to decline)
• Ambulatory without assistance
• Patients between 19 and 75 years of age
• Patients with Body Surface Area (BSA) of ? 1.7m2
• Sternum to T10 distance > 10cm OR adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments
• Cardiac transplant-eligible patients
• Patients who cannot be adequately anticoagulated on the TAH-t
• Patients with insufficient space in the chest
• Patients on ECMO support
• Patients with Cirrhosis (evidenced by ultrasound, CT scan, or positive biopsy)
• Patients with Acute or Chronic Renal dysfunction (per Intermacs AE Definitions)
• Patients with cardiac cachexia (e.g., pre-albumin <17, fragility, and catabolic/anabolic imbalance)
• Patients with a comorbidity that has a poor prognosis of survival beyond six months
• Patients with insufficient social support or who have demonstrated non-compliance with medical instructions (as determined by the Principal Investigator) Secondary Arm
• Patients who are NOT eligible to participate in the Primary Arm
• Patients with life-threatening, irreversible biventricular heart failure (Intermacs Patient Profile Classifications 1 - 7)
• Ineligible for cardiac transplantation (as determined by the implanting center at time of implant screening assessment).
• On optimal medical management and failing to respond or failing DT VAD therapy (continuing to decline)
• Patients 19 years of age or older
• Sternum to T10 distance > 10cm OR adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments
• Patients who are less than 19 years old
• Cardiac transplant-eligible patients
• Patients with Cirrhosis (evidenced by ultrasound, CT scan, or positive biopsy)
• Patients with Chronic Renal dysfunction (per Intermacs AE Definitions)
• Patients with insufficient space in the chest
• Patients who cannot be adequately anticoagulated on the TAH-t
• Patients with insufficient social support or who have demonstrated non-compliance with medical instructions (as determined by the Principal Investigator)
Inclusion Criteria:
• Patients with ife-threatening, irreversible biventricular heart failure (Intermacs Patient Profile Classifications 1 - 4)
• Ineligible for cardiac transplantation (e.g., contraindication to immunosuppression, cancer, elevated panel reactive antibodies [PRAs]) as determined by the implanting center at time of implant screening assessment.
• On optimal medical management and failing to respond or failing DT VAD therapy (continuing to decline)
• Ambulatory without assistance
• Patients between 19 and 75 years of age
• Patients with Body Surface Area (BSA) of ? 1.7m2
• Sternum to T10 distance > 10cm OR adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments
Exclusion Criteria:
• Cardiac transplant-eligible patients
• Patients who cannot be adequately anticoagulated on the TAH-t
• Patients with insufficient space in the chest
• Patients on ECMO support
• Patients with Cirrhosis (evidenced by ultrasound, CT scan, or positive biopsy)
• Patients with Acute or Chronic Renal dysfunction (per Intermacs AE Definitions)
• Patients with cardiac cachexia (e.g., pre-albumin <17, fragility, and catabolic/anabolic imbalance)
• Patients with a comorbidity that has a poor prognosis of survival beyond six months
• Patients with insufficient social support or who have demonstrated non-compliance with medical instructions (as determined by the Principal Investigator) Secondary Arm
Inclusion Criteria:
• Patients who are NOT eligible to participate in the Primary Arm
• Patients with life-threatening, irreversible biventricular heart failure (Intermacs Patient Profile Classifications 1 - 7)
• Ineligible for cardiac transplantation (as determined by the implanting center at time of implant screening assessment).
• On optimal medical management and failing to respond or failing DT VAD therapy (continuing to decline)
• Patients 19 years of age or older
• Sternum to T10 distance > 10cm OR adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments
Exclusion Criteria:
• Patients who are less than 19 years old
• Cardiac transplant-eligible patients
• Patients with Cirrhosis (evidenced by ultrasound, CT scan, or positive biopsy)
• Patients with Chronic Renal dysfunction (per Intermacs AE Definitions)
• Patients with insufficient space in the chest
• Patients who cannot be adequately anticoagulated on the TAH-t
• Patients with insufficient social support or who have demonstrated non-compliance with medical instructions (as determined by the Principal Investigator)
Device: 70cc TAH-t for Destination Therapy
Life-threatening, Biventricular Heart Failure, Ineligible for Cardiac Transplant
SynCardia, Total Artificial Heart, Biventricular heart failure, Ineligible for cardiac transplant
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 7 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Banner University Medical Center Phoenix, Arizona | |
| Banner University Medical Center Phoenix Phoenix, Arizona | |
| Cedars-Sinai Medical Center Los Angeles, California | |
| Froedtert & the Medical College of Wisconsin Milwaukee, Wisconsin | |
| Integris Baptist Medical Center Oklahoma City, Oklahoma | |
| Memorial Hermann Hospital Houston, Texas | |
| Virginia Commonwealth University Richmond, Virginia |
Active Temperature Management After Cardiac Surgery and Its Effect on Postoperative Cognitive Dysfunction
Rebecca Collen, MBA - rebecca.collen@vcuhealth.org
Yajnik, Vishal
NCT03947671
HM20015426
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• scheduled coronary artery bypass graft surgery patients, with or without valve surgery
• patients able to give informed consent
Exclusion Criteria:
• age < 20 years or > 89 years
• patients with unscheduled CABG +/- valve surgery (i.e. emergency surgery)
• deformity or skin condition of chest or thighs that would interfere with the successful placement of Rapr Round® vest and leg wraps
• patients presenting to the ICU postoperatively with a fever ≥ 38.3
• patients with planned intraoperative circulatory arrest
• prisoners
• pregnant patients
• patients with symptomatic cerebrovascular disease, specifically residual motor deficits, expressive or receptive aphasia from prior stroke or cerebrovascular accident
Device: Rapr Rounds Hyper/Hypothermia Wraps, Drug: Acetaminophen
Cardiac Surgery, Post-operative Cognitive Dysfunction, Fever
temperature regulation
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Rebecca Collen, MBA - (rebecca.collen@vcuhealth.org) Jessica Mason, MPH - (jessica.mason1@vcuhealth.org) |
Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention (PROSe-ICD)
Katherine Wu, MD - kwu@jhmi.edu
NCT00733590
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* History of acute MI at least 4 weeks old
* Non-ischemic LV dysfunction for at least 9 months
* Who have an ejection fraction (EF) \< or = to 35%
* Undergone elective replacement indicator (ERI) generator replacement of an FDA-approved ICD for primary prevention of SCD within 24 months of enrollment.
* Who have primary prevention implants.
Exclusion Criteria:
* ICD generator replacement for secondary prevention
* Inability or unwillingness to provide valid informed consent
* New York Heart Association Class IV heart failure
* Patients with pre-existing Class 1 indications for pacemaker therapy. Heart Failure, Congestive, Death, Sudden, Cardiac, Arrhythmia, Cardiomyopathies
defibrillator, implanted, genomics, electrocardiography, electrophysiological study, proteomics
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 4 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Johns Hopkins University School Of Medicine Baltimore, Maryland | Katherine Wu, MD - (kwu@jhmi.edu) |
| University of Maryland Medical Center Baltimore, Maryland | Stephen R Shorofsky, MD, PhD - (Sshorofs@medicine.umaryland.edu) |
| Virginia Commonwealth University School of Medicine Richmond, Virginia | Kenneth Ellenbogen, MD - (kellenbogen@pol.net) |
| Washington Hospital Center Washington D.C., District of Columbia | Zayd Eldadah, MD, PhD - (Zayd.Eldadah@Medstar.Net) |
A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
OHB Contact - CMO@Oakhillbio.com
Rozycki, Henry
NCT03253263
HM20016299
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• Written informed consents and/or assents must be signed and dated by the participant's parent(s) prior to any study related procedures. The informed consent and any assents for underage parents must be approved by the IRB/IEC (in accordance with local regulations).
• Written informed consents and/or assents must be signed and dated by the participant's birth mother prior to providing study-related information related to birth mother medical history, pregnancy and the birth of the participant. The informed consent and any assents for underage birth mothers must be approved by the IRB/IEC (in accordance with local regulations).
• Subjects must be between 23 weeks +0 days and 27 weeks +6 days GA, inclusive.
Exclusion Criteria:
• Detectable major (or severe) congenital malformation identified before randomization.
• Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigator's opinion.
• Hypoglycemia at Baseline (blood glucose less than (\<) 45 milligrams per deciliter \[mg/dL\] or 2.5 milli moles per liter \[mmol/L\]) which persists in spite of glucose supplementation, to exclude severe congenital abnormalities of glucose metabolism.
• Clinically significant neurological disease identified before randomization according to cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and investigator's opinion.
• Any other condition or therapy that, in the investigator's opinion, may pose a risk to the participant or interfere with the participant's potential compliance with this protocol or interfere with interpretation of results.
• Current or planned participation in a clinical study of another investigational study treatment, device, or procedure (participation in non-interventional studies is permitted on a case-by-case basis).
• The participant or participant's parent(s) is/are unable to comply with the protocol or is unlikely to be available for long-term follow-up as determined by the investigator.
• Birth mother with active COVID-19 infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy.
• Birth mother with known HIV or hepatitis (B, C, or E) infection.
DRUG: OHB-607
Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Intraventricular Hemorrhage, Retinopathy of Prematurity (ROP)
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 61 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Academisch Medisch Centrum Amsterdam Amsterdam-Zuidoost, North Holland | |
| Arkansas Children's Hospital Little Rock, Arkansas | |
| Ashford and St. Peter's Hospitals NHS Trust - St. Peter's Hospital Chertsey, Surrey | |
| Azienda Ospedaliera Di Padova Padua, | |
| Azienda Ospedaliero-Universitaria Careggi SOD Neonatologia e Terapia Intensiva Neonatale Florence, | |
| Boston Children's Hospital Boston, Massachusetts | |
| Centro Hospitalar Lisboa Lisbon, | |
| Centro Materno Infantil do Norte - Centro Hospital Universitario do Porto, E.P.E. Porto, | |
| Chelsea and Westminster NHS Trust London, | |
| Children's Hospital of Orange County Orange, California | |
| Children's Minnesota - Children's Hospital and Clinics Saint Paul, Minnesota | |
| Children's Minnesota - Children's Hospital and Clinics - St. Paul Saint Paul, Minnesota | |
| Cork University Maternity Hospital Cork, Wilton | |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan, MI | |
| Fondazione Policlinico Universitario A Gemelli Rome, Lazio | |
| Groupe Hospitalier Necker Enfants Malades Paris, | |
| Hopital Antoine Beclere Clamart, Hauts-de-Seine | |
| Hospital Garcia de Orta Almada, | |
| Hospital General Universitario Dr. Balmis Alicante, | |
| Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e Genova, | |
| Jackson Memorial Hospital Miami, Florida | |
| Kagoshima City Hospital Kagoshima, Kagoshima-ken | |
| Karolinska Solna Stockholm, | |
| Klinikum Nürnberg Nuremberg, | |
| Kurashiki Central Hospital Kurashikishi, Okayama-ken | |
| LAC USC Medical Center Los Angeles, California | |
| Liverpool Women's Hospital - PPDS Liverpool, | |
| Maastricht University Medical Center Maastricht, Limburg | |
| Maria Fareri Children's Hospital Valhalla, New York | |
| Maternidade Alfredo da Costa Lisbon, | |
| Medical University of South Carolina Children Hospital Charleston, South Carolina | |
| Memorial Hospital of South Bend South Bend, Indiana | |
| Mount Sinai Hospital New York, New York | |
| Nagano Children's Hospital Azumino, Nagano | |
| Nationwide Children's Hospital Columbus, Ohio | |
| Norfolk and Norwich University Hospital Norwich, Norfolk | |
| Norton Children's Hospital Louisville, Kentucky | |
| Ochsner Baptist Medical Center New Orleans, Louisiana | |
| Osaka Women's and Children's Hospital Izumi, Ôsaka | |
| Oulun Yliopistollinen Sairaala Oulu, | |
| Presidio Ospedaliero Di Treviso Ca' Foncello Treviso, | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Sainte Justine Hospital Montreal, Quebec | |
| Saitama Medical Center Saitama, | |
| Skanes universitetssjukhus Lund, | |
| St. Mary's Hospital Manchester, | |
| Tampa General Hospital Tampa, Florida | |
| Tufts Medical Center Boston, Massachusetts | |
| UVA Children's Hospital Charlottesville, Virginia | |
| Universitatsklinikum Freiburg Freiburg im Breisgau, Baden-Wurttemberg | |
| Universitatsklinikum Leipzig Leipzig, Saxony | |
| University College London London, | |
| University Hospital Coventry Coventry, | |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| University of Cambridge Cambridge, | |
| University of Illinois at Chicago Chicago, Illinois | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | |
| University of Rochester Rochester, New York | |
| Virginia Commonwealth University - Children's Hospital of Richmond at VCU Richmond, Virginia | |
| Wilhelmina Children Hospital-University Medical Center Utrecht Utrecht, |
Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients (SOLVE-CRT)
Nicholas Vesom - clinical@ebrsystemsinc.com
Ellenbogen, Kenneth, A
NCT02922036
HM20014794
Show full eligibility criteria
Hide eligibility criteria
Inclusion/Exclusion:
Inclusion Criteria
• Patient with a class I or IIa (1) or (2) indication for implantation of a CRT-D device according to current available guidelines (with additional QRS criteria on Class IIa (1)):
• Class I: NYHA II, III, IV, EF ≤ 35%, LBBB, QRS ≥ 150ms
• Class IIa (1): NYHA II, III, IV, EF≤ 35%, LBBB, QRS ≥ 130 to < 150ms
• Class IIa (2): NYHA II, III, IV, EF≤ 35%, non-LBBB, QRS ≥ 150ms
• Patient is a:
• 'Non-responder' [Not Enrolling]: Patients who have a CRT system that is functional and despite an adequate trial of Guideline Directed Medical Therapy (GDMT) and attempts at optimal device programming the patient has not responded to therapy for a minimum of 6 months. Non-response is defined as:
• EF has remained unchanged or worsened (defined as < 5% increase since implant), and
• The patient's clinical status based in the totality of available clinical evidence (such as NYHA Class, exercise tolerance, QOL, or global assessment) has remained unchanged or worsened, as determined by the local Site Enrollment Committee OR
• 'Previously Untreatable': Patients who have a full or partial CRT system, who meet general inclusion criteria and are deemed as 'previously untreatable' for one of the following reasons: i. Patients in whom CS lead implantation for CRT has failed
• CS lead implant was attempted but abandoned due any of the following: difficult CS access or anatomy, inadequate lead location, inadequate pacing thresholds, persistent phrenic nerve pacing, or other procedural challenges ii. CS lead implanted but has been programmed OFF
• LV lead that was implanted but not operational includes patients in whom the LV lead is inoperative or programmed off due to improper function such as high threshold, non-capture, phrenic nerve pacing, lead failure, lead dislodgement, or sub-optimal LV lead location OR c. 'High Risk Upgrade: Patients who have a relative contraindication to CS lead implant, due to:
• venous occlusion or lesion precluding implant
• pocket infection risk (at co-implanted device site)
• considered high risk for CS implant due to co-morbidities
• Patients on a stable Guideline Directed Medical Therapy (GDMT)
• Patient must be 18 years old or over
• Patient has signed and dated informed consent
• Patient has suitable anatomy for implant of the WiSE CRT System (e.g. adequate acoustic window, LV wall thickness in target implant area ≥ 5 mm, absence of LV wall structural abnormalities which may preclude implant) Exclusion Criteria Patients who meet any one of these criteria will be excluded from the investigation:
• Pure RBBB
• LVEDD ≥ 8cm
• Non-ambulatory or unstable NYHA class IV
• Contraindication to heparin, chronic anticoagulants or antiplatelet agents
• Triple anticoagulant patients who cannot tolerate peri-procedural stopping of anticoagulation therapy
• Attempted device implant (pacemaker, ICD, CRT, LV lead) or successful co-implant within prior 30 days.
• Patients with planned or expected lithotripsy treatment post implant
• Life expectancy of < 12 months
• Chronic hemodialysis
• Stage 4 or 5 renal dysfunction defined as eGFR < 30
• Grade 4 mitral valve regurgitation
• Noncardiac implanted electrical stimulation therapy devices
• Patients with a prosthetic aortic valve in which the electrode cannot be implanted via a transseptal approach
• Patients with a prosthetic mitral valve in which the electrode cannot be implanted via a retrograde aortic approach
• Unstable angina, acute MI, CABG, or PTCA within the past 1 month
• Correctable valvular disease that is the primary cause of heart failure
• Recent CVA or TIA (within the previous 3 months)
• Patients with a history of paroxysmal or persistent atrial fibrillation/flutter are excluded if they have had a documented AF episode > 30 min or a cardioversion in the past 1 month.
• Patients with permanent AF are excluded if they have intact AV node conduction (RV pacing <95%)
• Already included in another clinical study that could confound the results of this study
• Pregnancy
• Known drug or alcohol addiction or abuse
• Moderate or severe aortic stenosis
• Subject unable to attend follow-up at the investigative center or unable, for physical or mental reasons, or to comply with the trial's procedures
• For Part II Randomized patients only, those who will not tolerate being randomized to the Control Group for 6 months
• Patient with a class I or IIa (1) or (2) indication for implantation of a CRT-D device according to current available guidelines (with additional QRS criteria on Class IIa (1)):
• Class I: NYHA II, III, IV, EF ≤ 35%, LBBB, QRS ≥ 150ms
• Class IIa (1): NYHA II, III, IV, EF≤ 35%, LBBB, QRS ≥ 130 to < 150ms
• Class IIa (2): NYHA II, III, IV, EF≤ 35%, non-LBBB, QRS ≥ 150ms
• Patient is a:
• 'Non-responder' [Not Enrolling]: Patients who have a CRT system that is functional and despite an adequate trial of Guideline Directed Medical Therapy (GDMT) and attempts at optimal device programming the patient has not responded to therapy for a minimum of 6 months. Non-response is defined as:
• EF has remained unchanged or worsened (defined as < 5% increase since implant), and
• The patient's clinical status based in the totality of available clinical evidence (such as NYHA Class, exercise tolerance, QOL, or global assessment) has remained unchanged or worsened, as determined by the local Site Enrollment Committee OR
• 'Previously Untreatable': Patients who have a full or partial CRT system, who meet general inclusion criteria and are deemed as 'previously untreatable' for one of the following reasons: i. Patients in whom CS lead implantation for CRT has failed
• CS lead implant was attempted but abandoned due any of the following: difficult CS access or anatomy, inadequate lead location, inadequate pacing thresholds, persistent phrenic nerve pacing, or other procedural challenges ii. CS lead implanted but has been programmed OFF
• LV lead that was implanted but not operational includes patients in whom the LV lead is inoperative or programmed off due to improper function such as high threshold, non-capture, phrenic nerve pacing, lead failure, lead dislodgement, or sub-optimal LV lead location OR c. 'High Risk Upgrade: Patients who have a relative contraindication to CS lead implant, due to:
• venous occlusion or lesion precluding implant
• pocket infection risk (at co-implanted device site)
• considered high risk for CS implant due to co-morbidities
• Patients on a stable Guideline Directed Medical Therapy (GDMT)
• Patient must be 18 years old or over
• Patient has signed and dated informed consent
• Patient has suitable anatomy for implant of the WiSE CRT System (e.g. adequate acoustic window, LV wall thickness in target implant area ≥ 5 mm, absence of LV wall structural abnormalities which may preclude implant) Exclusion Criteria Patients who meet any one of these criteria will be excluded from the investigation:
• Pure RBBB
• LVEDD ≥ 8cm
• Non-ambulatory or unstable NYHA class IV
• Contraindication to heparin, chronic anticoagulants or antiplatelet agents
• Triple anticoagulant patients who cannot tolerate peri-procedural stopping of anticoagulation therapy
• Attempted device implant (pacemaker, ICD, CRT, LV lead) or successful co-implant within prior 30 days.
• Patients with planned or expected lithotripsy treatment post implant
• Life expectancy of < 12 months
• Chronic hemodialysis
• Stage 4 or 5 renal dysfunction defined as eGFR < 30
• Grade 4 mitral valve regurgitation
• Noncardiac implanted electrical stimulation therapy devices
• Patients with a prosthetic aortic valve in which the electrode cannot be implanted via a transseptal approach
• Patients with a prosthetic mitral valve in which the electrode cannot be implanted via a retrograde aortic approach
• Unstable angina, acute MI, CABG, or PTCA within the past 1 month
• Correctable valvular disease that is the primary cause of heart failure
• Recent CVA or TIA (within the previous 3 months)
• Patients with a history of paroxysmal or persistent atrial fibrillation/flutter are excluded if they have had a documented AF episode > 30 min or a cardioversion in the past 1 month.
• Patients with permanent AF are excluded if they have intact AV node conduction (RV pacing <95%)
• Already included in another clinical study that could confound the results of this study
• Pregnancy
• Known drug or alcohol addiction or abuse
• Moderate or severe aortic stenosis
• Subject unable to attend follow-up at the investigative center or unable, for physical or mental reasons, or to comply with the trial's procedures
• For Part II Randomized patients only, those who will not tolerate being randomized to the Control Group for 6 months
Device: WiSE System
Heart Failure
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 84 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| APHM-Hopital de La Timone Marseille, | Imène Kara - (Imene.KARA@ap-hm.fr) |
| AtlantiCare Regional Medical Center Pomona, New Jersey | Jackie White - (jacqueline.white@atlanticare.org) |
| Aurora St. Luke's Medical Center Milwaukee, Wisconsin | Rebecca Stebnitz - (rebecca.stebnitz@aurora.org) |
| Banner University Medical Center Phoenix, Arizona | |
| Baptist Health Lexington Lexington, Kentucky | Gwyn Middleton - (gmiddlet@bhsi.com) |
| Barts Heart Centre London, | |
| Broward Health Medical Center Fort Lauderdale, Florida | Debra Ayer - (dayer@browardhealth.org) |
| CHU Grenoble - Hopital Michallon Service de Cardiologie Grenoble, | |
| CHU-Hopital Pontchaillou Rennes, | |
| Canberra Hospital Garran, Australian Capital Territory | |
| Centre Cardiologique du Nord Paris, | |
| Cleveland Clinic Cleveland, Ohio | Raquel Rozich - (rozichr@ccf.org) |
| Clinique Pasteur Toulouse Toulouse, | |
| Emory HealthCare Atlanta, Georgia | Leon Darghosian - (leon.darghosian@emory.edu) |
| Fiona Stanley Hospital Murdoch, | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Henry Ford Hospital Detroit, Michigan | |
| Honor Health Scottsdale, Arizona | |
| Houston Methodist Houston, Texas | Sheila Moore - (srmoore@houstonmethodist.org) |
| Immanuel Klinikum Bernau - Herzzentrum Brandenburg Bernau, | |
| Intermountain Medical Center Murray, Utah | Lindsey Bevan - (Lindsey.Bevan@imail.org) |
| Isala Hartcentrum Zwolle, | |
| James Cook University Hospital Central Middlesbrough, Middlesbrough | |
| John Hunter Hospital New Lambton Heights, New South Wales | |
| John Radcliffe Hospital Oxford, | |
| Kansas City Heart Rhythm Institute Overland Park, Kansas | |
| Keck Medical Center of USC Los Angeles, California | |
| Liverpool Heart and Chest Hospital Liverpool, Merseyside | |
| MUSC Gazes Research Institute Charleston, South Carolina | Kavin Panneerselvam - (panneeer@musc.edu) |
| Manchester Heart Centre Manchester, | |
| Massachusetts General Hospital Boston, Massachusetts | |
| Mayo Clinic Rochester, Minnesota | Brian Liddell - (liddell.brian@mayo.edu) |
| Methodist Physicians Clinic Heart Consultants Omaha, Nebraska | Dru McMartin - (dru.mcmartin@nmhs.org) |
| Michigan Heart Ypsilanti, Michigan | Autumn Howe - (ahowe@MichiganHeart.com) |
| Minneapolis Heart Institute Minneapolis, Minnesota | Jessica Whelan - (Jessica.Whelan@allina.com) |
| Monash Heart Clayton, Victoria | |
| Mount Sinai Hospital New York, New York | |
| Naples Community Hospital Naples, Florida | Anessa Diers - (anessa.diers@nchmd.org) |
| North Mississippi Health Services Tupelo, Mississippi | |
| Northside Hospital and Heart Institute Saint Petersburg, Florida | Patricia Nelson - (patricia.nelson@hcahealthcare.com) |
| Ochsner Medical Center - Baton Rouge Baton Rouge, Louisiana | Melanie Lunn - (mlunn@ochsner.org) |
| Ospedale San Gerardo Monza, | |
| PeaceHealth Vancouver, Washington | Penny O'Leary - (POLeary@peacehealth.org) |
| Penn State Health, Hershey Medical Center Hershey, Pennsylvania | Lisa Fox - (lfox5@pennstatehealth.psu.edu) |
| Piedmont Heart Institute Atlanta, Georgia | Megan Kopp - (Megan.Kopp@piedmont.org) |
| Policlinico S. Orsola Bologna, | |
| Prairie Heart Springfield, Illinois | Lauren Bainter - (lbainter@prairieresearch.com) |
| Prince of Wales Hospital Grimsby, | |
| Royal Adelaide Hospital Adelaide, | |
| Royal Prince Alfred Hospital Camperdown, New South Wales | |
| Rutgers University New Brunswick, New Jersey | Jamie Lau - (Jamie.lau@rutgers.edu) |
| Saint Luke's Health System Kansas City Kansas City, Kansas | Susan Reifenrath - (sehlert@saint-lukes.org) |
| Sentara Healthcare Newport News, Virginia | Kelly Jordan - (KNJORDA1@sentara.com) |
| Sequoia Hospital Redwood City, California | |
| Sparrow Hospital Lansing, Michigan | |
| St. Thomas Hospital London, Tennessee | |
| St. Vincent's Healthcare Jacksonville, Florida | Lisa Joseph - (Lisa.Joseph@ascension.org) |
| St. Vincent's Hospital and Healthcare Center Indianapolis, Indiana | Regina Margiotti - (regina.margiotti@ascension.org) |
| Stern Cardiovascular Center Germantown, Tennessee | Kari Fondren - (kari.fondren@sterncardio.com) |
| Texas Heart Institute Houston, Texas | |
| The Alfred Hospital Melbourne, Victoria | |
| The Heart Center Huntsville, Alabama | Maryann Soli - (msoli@theheartcenter.md) |
| The Heart Hospital Baylor Plano Plano, Texas | Walter Cerqueira - (walter.cerqueira@bswhealth.org) |
| The Ohio State University Columbus, Ohio | Toshimasa Okabe, MD |
| The University of Kansas Medical Center Kansas City, Kansas | Quratulain "Annie" Mushtaq - (qmushtaq@kumc.edu) |
| The University of Texas Health Science Center at Houston Houston, Texas | Mary Pierce - (Mary.H.Pierce@uth.tmc.edu) |
| UPMC Heart and Vascular Institute Pittsburgh, Pennsylvania | |
| United Heart and Vascular Clinic Saint Paul, Minnesota | Jessie Whelan - (jessica.whelan@allina.com) |
| University of California, San Diego La Jolla, California | Sandeep Toomu - (satoomu@health.ucsd.edu) |
| University of Chicago Chicago, Illinois | Shahram Sarrafi - (ssarrafi1@medicine.bsd.uchicago.edu) |
| University of Illinois Hospital & Health Sciences System Chicago, Illinois | |
| University of Iowa Iowa City, Iowa | Trisha Elliott - (trisha-elliott@uiowa.edu) |
| University of Michigan Ann Arbor, Michigan | Sangeeta Lathkar-Pradham - (slathkar@med.umich.edu) |
| University of Pennsylvania Philadelphia, Pennsylvania | |
| University of Virginia Charlottesville, Virginia | Amanda Lyons - (ACL3Q@hscmail.mcc.virginia.edu) |
| Universitäres Herzzentrum Hamburg (UKE Hamburg) GmbH (UHZ) Hamburg, | |
| Universitätsklinikum Erlangen Erlangen, Bavaria | |
| Universitätsklinikum Münster Münster, North Rhine-Westphalia | |
| VCU Medical Center Richmond, Virginia | |
| Virtua Lourdes Cardiology Cherry Hill, New Jersey | |
| Watson Clinic Lakeland, Florida | Linda Bell - (LBell2@watsonclinic.com) |
| Weill Cornell Medical Center New York, New York | |
| William Beaumont Hospital Royal Oak, Michigan | Jon Teefey - (Jon.Teefey@beaumont.org) |
| Yale University New Haven, Connecticut |
Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function (PROTECT IV)
Charles (Chuck) Simonton, MD FACC FSCAI - csimonton@abiomed.com
NCT04763200
Pending IRB#
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• Age ≥18 years and ≤90 years
• Clinical presentation and baseline left ventricular function are as follows: Either 2A or 2B must be present A. Subject has CCS or NSTEMI with an LVEF ≤40% NOTE: The LVEF must be quantitatively measured as ≤40% by echo within 30 days assuming no change in clinical condition. If multiple echos have been performed within 30-days, the most recent test must be used to qualify the patient. NOTE: Subject qualifies if the quantitative site read LVEF is ≤30%; if the quantitative site read is \>30% - ≤40% the Echo Core Lab must confirm the LVEF is ≤40% before subject enrollment (Core Lab will provide \<48-hour turnaround). Similarly, if the site read is qualitative only (i.e., only provides broad ranges without detailed LVEF quantification), the Echo Core Lab must confirm the LVEF is ≤40% before subject enrollment. OR B. Subject has STEMI ≥24 hours and \<30 days after symptom onset with an LVEF ≤30% NOTE: In patients qualifying with recent STEMI, the LVEF must be demonstrated to be ≤30% by quantitative echocardiography after the primary PCI procedure (if performed) and within 72-hours prior to the planned randomization. If primary PCI was not performed, the qualifying echocardiogram will be the one taken during the index hospitalization closest to the index procedure. If the site read is qualitative only (i.e., only provides broad ranges without detailed LVEF quantification), the Echo Core Lab must confirm the LVEF is ≤30% before subject enrollment.
• Local heart team (interventional cardiologist and cardiac surgeon) has determined that PCI is indicated and is the most appropriate management for the patient
• Complex PCI will be performed: Either 4A or 4B must be met A. One of the following must be present: i. Triple vessel disease is present (visually-assessed angiographic DS ≥80% \[or ≥40% if non-invasive evidence of ischemia on a localizing stress test or invasive evidence of ischemia (FFR ≤0.80 or iFR ≤0.89)\] is present in all 3 epicardial coronary artery distributions in a main vessel or branch with visually-assessed reference vessel diameter ≥2.5 mm) with PCI planned in ≥2 of these vessels in the proximal or mid LAD, proximal or mid-LCX or proximal, mid- or distal RCA \[i.e., not a branch vessel\]) OR ii. Left main distal bifurcation or trifurcation disease (visually-assessed DS ≥50% \[or DS ≥30% if non-invasive evidence of ischemia in both the anterior and posterolateral distributions or left main IVUS MLA ≤6.0 mm2 or FFR ≤0.80 or iFR ≤0.89\] is present) with planned intervention of the left main plus at least 2 branch vessels (i.e., the ostial LAD, ostial LCX or ostial ramus) OR iii. Left main equivalent disease with both ostial LAD and ostial LCX having visually-assessed angiographic DS ≥80% \[or ≥40% if non-invasive evidence of ischemia on a localizing stress test or invasive evidence of ischemia (FFR ≤0.80 or iFR ≤0.89\] and requiring intervention in both branches OR iv. Intervention of the last remaining vessel (native coronary artery or bypass graft) OR B. Multivessel disease is present (visually-assessed angiographic DS ≥80% \[or ≥40% if non-invasive or invasive evidence of ischemia is present\] in ≥2 of the 3 epicardial coronary artery distributions in a main vessel or branch with visually-assessed reference vessel diameter ≥2.5 mm) and PCI is planned of at least 2 separate complex lesions in main vessels or branch vessels each having one or more of the following characteristics: i. Long lesion (≥28 mm visually assessed) requiring ≥30 mm stent length (single or multiple) ii. Severe angiographic calcification (see Protocol definition) or requiring atheroablation iii. Any left main morphology not in Criterion A requiring intervention (e.g., isolated ostial or mid-shaft left main lesion or distal left main bifurcation lesion with a planned single provisional stent technique) iv. Non-left main bifurcation lesion requiring intervention in both the main branch and side branch v. CTO (TIMI 0 Flow) vi. Giant thrombus (length ≥3x vessel diameter) vii. SVG (other than focal (\<5 mm) disease of the proximal or distal anastomosis or in-stent restenosis) NOTES:
• The multiple lesions can be in the same vessel if separated by ≥10 mm - however, each separate lesion has to have one or more of the above characteristics
• PCI may be performed on additional non-qualifying lesions (i.e., without 1 or more of the above high-risk characteristics) as long as there are at least two lesions also undergoing PCI with each having 1 or more of the above characteristics)
• There are 2 exceptions to the rule that each separate lesion must have one or more of the above characteristics (as in Inclusion Criterion 4B above): The subject may qualify if undergoing complex PCI of a single lesion that has 2 or more of the above complex characteristics (as in Inclusion Criterion 4B above) if also: i. There is a CTO of a proximal or mid-LAD, proximal or mid-LCX or proximal, mid- or distal RCA (i.e., not a branch vessel) that will not be treated OR ii. The subject qualifies with recent STEMI with an LVEF ≤30% and the complex PCI is planned in a non-infarct vessel (i.e., a complex PCI in the infarct vessel does not qualify)
• Subject or legal guardian (permitted at US sites only) agrees to randomization and to follow all study procedures and provides informed, written consent
Exclusion Criteria:
Subjects must not meet ANY of the following Exclusion Criteria to participate in the Trial:
• STEMI ≤24 hours from the onset of ischemic symptoms or at any time if mechanical complications of transmural infarction are present (e.g., VSD, papillary muscle rupture, etc.)
• Cardiogenic shock (SBP \<80 mmHg for ≥30 mins and not responsive to intravenous fluids or hemodynamic deterioration for any duration requiring pressors or mechanical circulatory support, including IABP)
• Subject is presently or recently intubated for the current admission (NOTE: recently intubated patients must be extubated for \>24 hours with full neurologic recovery)
• Cardiorespiratory arrest related to the current admission unless subject is extubated for \>24 hours with full neurologic recovery and hemodynamically stable
• Any contraindication or inability to Impella placement in both the left and right common femoral artery based on clinical or imaging findings, including iliofemoral artery diameter \<5 mm, tortuous vascular anatomy or severe bilateral peripheral vascular disease of the iliac or femoral arteries that can't be adequately treated (e.g., with intravascular lithotripsy) NOTES:
• Computed tomography (CT), magnetic resonance angiography (MRA) or contrast angiography to assess the aorta and iliofemoral vasculature to ensure Impella compatibility must be performed within 90 days prior to randomization. It is recommended that this evaluation be performed prior to the index procedure. Absent a qualifying pre-procedure imaging study, contrast angiography of the potential Impella access vessel(s) must be performed in the Cath Lab before the planned enrollment after which the subject may be randomized if he/she still qualifies. Of note, if pre-procedure imaging was performed and after this test but before randomization there was a worsening in PVD symptoms, repeat imaging must be performed prior to randomization.
• If iliofemoral peripheral vascular disease is present precluding Impella use that can be adequately treated with angioplasty, atherectomy or lithotripsy (without a stent), the subject can be enrolled if such treatment is undertaken and is successful and uncomplicated - randomization must not be performed until such successful and uncomplicated treatment
• Iliofemoral stents placed within 6 months of enrollment with planned vascular access through these vascular segments
• Vascular access for Impella is required in any location other than the left or right common femoral artery (i.e., axillary access, transcaval access, etc., for Impella access are not permitted)
• Known left ventricular thrombus
• Incessant ventricular arrhythmias that would likely preclude stable Impella positioning
• Severe aortic stenosis or severe aortic insufficiency
• Prior mechanical valve or self-expanding TAVR (NOTE: prior bioprosthetic surgical valve or balloon expandable TAVR implanted \>24 hours pre-procedure is acceptable)
• Prior CABG within three (3) months or successful prior PCI of at least one (1) attempted lesion within 12 months (including during the index hospitalization prior to randomization), that has not experienced stent thrombosis or restenosis during that 12-month period; the one (1) exception is that patients may be enrolled if a primary PCI for STEMI was performed during the index hospitalization without MCS and that was ≥24 hours and \<30 days prior to randomization. NOTE: Successful PCI for this exclusion criterion is defined as a visually-assessed angiographic DS ≤50% in at least one (1) attempted lesion.
• Prior placement of IABP, Impella or any other MCS device for any reason during the index admission, prior to randomization
• Known severe pulmonary hypertension (right ventricular systolic pressure (RVSP) on echo or pulmonary artery systolic pressure (PASP) on right heart catheterization) \>70 mm Hg unless active vasodilator therapy in the Cath Lab is able to reduce the pulmonary vascular resistance (PVR) to \<3 Wood Units or between 3 and 4.5 Wood Units with v-wave less than twice the mean of the pulmonary capillary wedge pressure
• Symptoms or signs of severe RV dysfunction, such as anasarca (NOTE: Leg edema alone does not necessarily indicate severe RV dysfunction if the investigator believes it is due to LV dysfunction)
• Severe tricuspid insufficiency
• Platelet count \<75,000 cells/mm3, bleeding diathesis or active bleeding, coagulopathy or unwilling to receive blood transfusions
• On dialysis
• Prior stroke with any permanent neurologic deficit within the previous three (3) months, or any prior intracranial hemorrhage or any prior subdural hematoma or known intracranial pathology pre-disposing to intracranial bleeding, such as an arteriovenous malformation or mass
• Taking a chronic oral anticoagulant that cannot be safely discontinued for at least 72-hours before and 72-hours after the index procedure (if a vitamin K antagonist) or that cannot be safely discontinued for at least 48 hours before and 48 hours after the index procedure (for a direct acting oral anticoagulant)
• Plan for any surgery within 6 months necessitating discontinuing antiplatelet agents
• Pregnant or child-bearing potential unless negative pregnancy test within 1 week
• Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint
• Any medical or psychiatric condition such as dementia, alcoholism or substance abuse which may preclude informed consent or interfere with any of the study procedures, including follow-up visits
• Any non-cardiac condition with life expectancy \<3 years (e.g., cirrhosis, oxygen or oral steroid dependent COPD, cancer not in remission, etc.)
• Subject is currently hospitalized for definite or suspected COVID-19
• Subject has previously been symptomatic with or hospitalized for COVID-19 unless he/she has been discharged (if hospitalized) and asymptomatic for ≥4 weeks and has returned to his/her prior baseline (pre-COVID) clinical condition
• Subject is asymptomatic (never ill) and COVID-19 PCR/antigen test is positive within the prior four (4) weeks unless a) subject remains asymptomatic for ≥2 weeks after the last positive test or b) the positive test occurred within six (6) months after the subject received a COVID vaccine
• Subject belongs to a vulnerable population (defined as individuals with mental disability, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention)
DEVICE: Impella CP® / Impella CP® with SmartAssist® / Impella 2.5®, DEVICE: IABP Intra-aortic balloon pump
Left Ventricular Dysfunction, Coronary Artery Disease
Non-ST Elevated Myocardial Infarction, Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia, Myocardial Infarction, Anterior Wall Myocardial Infarction, Inferior Wall Myocardial Infarction
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 134 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Abrazo Arizona Heart Phoenix, Arizona | |
| AdventHealth - Tampa Tampa, Florida | |
| Adventist Health Glendale Glendale, California | |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Allegheny General Hospital Pittsburgh, Pennsylvania | |
| Arkansas Cardiology Little Rock, Arkansas | |
| Ascension St. Thomas West Nashville, Tennessee | |
| Aurora St. Luke's Medical Center Milwaukee, Wisconsin | |
| Baylor Scott & White Heart - Plano Plano, Texas | |
| Berlin CBF Berlin, | |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | |
| CVK Berlin Berlin, | |
| Cardiology Associates Research Company Daytona Beach, Florida | |
| Cardiovascular Institute of the South (Lafayette General Medical Center) Lafayette, Louisiana | |
| Cardiovascular Research Institute of Kansas Wichita, Kansas | |
| Carilion Clinic Roanoke, Virginia | |
| Catharina Ziekenhuis Eindhoven Eindhoven, | |
| Catholic Medical Center Manchester, New Hampshire | |
| Cedars-Sinai Medical Center Los Angeles, California | |
| Centennial Heart - Nashville Nashville, Tennessee | |
| CentraCare (St. Cloud Hospital) Saint Cloud, Minnesota | |
| Cleveland Clinic Foundation Cleveland, Ohio | |
| Clinica Mediterranea Napoli, | |
| Colorado Heart and Vascular Lakewood, Colorado | |
| Columbia University Medical Cenrer/NYPH New York, New York | |
| Corewell Health Grand Rapids, Michigan | |
| Duke University Durham, North Carolina | |
| Emory University Hospital Atlanta, Georgia | |
| Englewood Hospital Englewood, New Jersey | |
| Greenville Hospital System Greenville, South Carolina | |
| HCA Houston Healthcare Houston, Texas | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Hartford Hospital Hartford, Connecticut | |
| Henry Ford Hospital Detroit, Michigan | |
| Henry Ford St. John Hospital Detroit, Michigan | |
| Herzzentrum Dresden GmbH Dresden, | |
| Houston Methodist Hospital Houston, Texas | |
| Humanitas Clinical & Research Hospital Rozzano, Lombardy | |
| Icahn School of Medicine at Mt. Sinai New York, New York | |
| Inselspital Bern Bern, | |
| Istituto Cardiocentro Ticino Lugano, Tessin | |
| Jersey Shore University Medical Center Neptune City, New Jersey | |
| Keck School of Medicine of USC Los Angeles, California | |
| Klinikum Chemnitz gGmbH Chemnitz, | |
| Klinikum Friedrichshafen GmbH Friedrichshafen, | |
| Klinikum Karlsburg Karlsburg, Mecklenburg-Vorpommern | |
| Klinikum rechts der Isar der TUM Munich, Bavaria | |
| Krankenhaus der Barmherzigen Brüder Vienna, | |
| LUMC-Leids Universitair Medisch Centrum Leiden, Zuid | |
| Legacy Emanuel Hospital & Health Center Portland, Oregon | |
| Lehigh Valley Health Network Allentown, Pennsylvania | |
| Linder Research Center (The Christ Hospital) Cincinnati, Ohio | |
| Loma Linda University Health Loma Linda, California | |
| Lovelace/New Mexico Heart Institute Albuquerque, New Mexico | |
| Luzerner Kantonsspital Lucerne, | |
| Massachusetts General Hospital Boston, Massachusetts | |
| Medical City Fort Worth Fort Worth, Texas | |
| Medical College of Wisconsin Milwaukee, Wisconsin | Barbara Shimada-Krouwer, RN - (bshikrouwer@mcw.edu) |
| Medstar Washington Hospital Center Washington D.C., District of Columbia | |
| Memorial Hermann Texas Medical Center (UT Health) Houston, Texas | |
| Memorial Medical Center Modesto, California | |
| Methodist Hospital - San Antonio San Antonio, Texas | |
| Metropolitan Heart and Vascular Institute / Metropolitan Cardiology Consultants Coon Rapids, Minnesota | |
| Mills-Peninsula Medical Center Burlingame, California | |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Montefiore Medical Center - Moses Bronx, New York | |
| Monument Health Clinical Research Rapid City, South Dakota | |
| Morristown Medical Center Morristown, New Jersey | |
| NYU Langone Health New York, New York | |
| North Carolina Heart and Vascular Research Raleigh, North Carolina | |
| NorthShore University Health System Skokie, Illinois | |
| Northside Cardiovascular Institute Lawrenceville, Georgia | |
| Northwell University Hospital Manhasset, New York | |
| Northwest Medical Center Tucson Tucson, Arizona | |
| Northwestern University Chicago, Illinois | |
| Norton Healthcare - Norton Heart Specialists Louisville, Kentucky | |
| Ochsner Foundation Hospital New Orleans, Louisiana | |
| Oregon Health and Science University Portland, Oregon | |
| Ospedale di San Donato San Donato Milanese, | |
| Parkwest Medical Center Knoxville, Tennessee | |
| Policlinico Universitario Agostino Gemelli Rome, Lazio | |
| Presbyterian Hospital Dallas / Texas Health Physicians Group Dallas, Texas | |
| Providence St. Vincent Medical Center Portland, Oregon | |
| Robert Wood Johnson Medical School & Robert Wood Johnson University Hospital New Brunswick, New Jersey | |
| Royal Brompton Hospital London, | |
| Royal Victoria Hospital Montréal, Quebec | |
| Rush University Medical Center Chicago, Illinois | |
| SSM Health DePaul Hospital Bridgeton, Missouri | |
| Saint Agnes Medical Center Fresno, California | |
| Sanger Heart and Vascular Institute Charlotte, North Carolina | |
| Segeberger Kliniken GmbH Bad Segeberg, | |
| Sentara Norfolk Health System Norfolk, Virginia | |
| St. Boniface Hospital Winnipeg, Manitoba | |
| St. Francis Hospital and Heart Center Roslyn, New York | |
| St. Joseph Hospital - Orange Orange, California | |
| St. Joseph's Medical Center - Phoenix Phoenix, Arizona | |
| St. Luke's Hospital Kansas City, Missouri | |
| St. Vinzenz-Hospital Gmbh Köln Köln, | |
| Stony Brook University Hospital (SUNY) Stony Brook, New York | |
| Texas Cardiology Associates of Houston Kingwood, Texas | |
| Texas Heart Institute at Baylor St. Luke's Hospital Houston, Texas | |
| The Cardiac & Vascular Institute Gainesville, Florida | |
| The Queen's Medical Center Honolulu, Hawaii | |
| The Valley Hospital - Ridgewood Ridgewood, New Jersey | |
| Toronto General Hospital Toronto, Ontario | |
| Torrance Memorial Medical Center Torrance, California | |
| Tucson Medical Center HealthCare Tucson, Arizona | |
| Tufts Medical Center Boston, Massachusetts | |
| UCSD Medical Center San Diego, California | |
| UF Health Jacksonville Jacksonville, Florida | |
| Uniklinik Würzburg Würzburg, | |
| University Hopsital Frankfurt Frankfurt, | |
| University Hospital Aachen Aachen, | |
| University Hospital Padua Padua, | |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | |
| University at Buffalo/Kaleida Health Buffalo, New York | |
| University of Alabama Birmingham, Alabama | |
| University of Florida Health - Gainesville Gainesville, Florida | |
| University of Oklahoma Medical Center Oklahoma City, Oklahoma | |
| University of Texas Medical Branch (UTMB) Galveston Galveston, Texas | |
| University of Washington Medical Center Seattle, Washington | |
| Universitätsklinikum Düsseldorf Düsseldorf, | |
| Universitätsklinikum Erlangen Erlangen, Bavaria | |
| Universitätsklinikum Essen AöR Essen, | |
| Universitätsklinikum Freiburg, Universitäts-Herzzentrum Bad Krozingen, | |
| Universitätsklinikum Gießen Gießen, | |
| VCU Medical Center Richmond, Virginia | |
| Vanderbilt University Medical Center Nashville, Tennessee | |
| Wake Forest University Health Sciences Winston-Salem, North Carolina | |
| Washington Regional Medical Center - Walker Heart Institute Fayetteville, Arkansas | |
| WellSpan York Hospital York, Pennsylvania | |
| Wellmont Cardiology Services Kingsport, Tennessee | |
| Wellstar Kennestone Hospital Marietta, Georgia | |
| West Virginia University Hospital Morgantown, West Virginia |
Interleukin-1 Blockade in Acute Myocardial Infarction to Prevent Heart Failure (VA-ART4)
Benjamin Van Tassell, PharmD - bvantassell@vcu.edu
Abbate, Antonio
NCT05177822
HM20022826
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
All criteria need to be met.
* Acute ST segment elevation myocardial infarction defined as:
* chest pain, consistent with angina, within the prior 12 hours (for intermittent pain lasting more than 12 hours, the time from the when the pain became severe and constant);
* ST segment elevation on ECG \>1 mm in 2 or more anatomically contiguous leads;
* Reperfusion strategy planned or completed (including percutaneous coronary intervention or fibrinolysis)
* Age \>21 years.
Exclusion Criteria:
Subjects will not be eligible if they meet any of the following exclusion criteria.
* Pregnancy;
* Inability to obtain consent from patient;
* History of prior STEMI or of systolic heart failure (LVEF\<40%);
* Contraindications to treatment with anakinra (i.e. prior allergic reaction to Kineret® or E. coli derived products);
* Duration of chest pain \>12 hours at time of coronary artery catheterization (continuously - see exceptions in Inclusion Criteria) or coronary artery intervention \>12 hours earlier (see exceptions in Inclusion Criteria)\[max duration of chest pain 24 hours\];
* Failed reperfusion strategy (unsuccessful percutaneous coronary intervention);
* Need or plan for emergent cardiac surgery;
* Anticipated inability to complete a cardiopulmonary exercise test (CPET) on a treadmill at follow up visit at 42 days (i.e. amputee, wheel-chair bound, severe non-cardiac illness limiting mobility).
* Active infection (such as acute, i.e. COVID-19, or chronic/recurrent infectious disease i.e HBV, HCV, and HIV/AIDS-but excluding HCV+ patients with undetectable plasma RNA)
* Acute or chronic inflammatory disease or immunosuppressive therapies (including oral corticosteroids at a dose of prednisone equivalent of 0.5 mg/kg/day but not including inhaled or low dose oral corticosteroids or non-steroidal anti-inflammatory drugs).
* Neutropenia (\<1,500/mm3 or \<1,000/mm3 in African-American patients).
* Active acute or chronic psychiatric illness that in the opinion of the investigator may prevent from complying with study instructions;
* Stage V chronic kidney disease (estimated glomerular filtration rate 15 mL/min/1.73m2 or less) or on renal-replacement therapy (a GFR ≥45 mL/min/1.73m2 is required for the cardiac magnetic resonance portion of the study);
* Limited English Proficiency that in the opinion of the investigator may prevent from understanding the content of the informed consent form and instructions during the tests required for the study.
* Any comorbidity limiting survival or ability to complete the study. DRUG: Anakinra, OTHER: Placebo
Heart Failure
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 2 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| University of Virginia Charlottesville, Virginia | Linda Bryceland, RN, CCRC - (lgs2m@virginia.edu) |
| Virginia Commonwealth University Richmond, Virginia | Benjamin Van Tassell, PharmD - (bvantassell@vcu.edu) |
Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan (TREAT-HF)
Massey CTO CPC Team - masseycpc@vcu.edu
Bottinor, Wendy
NCT05194111
HM20023601
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Age \/=40% on echocardiogram or cardiac MRI
* No symptoms of heart failure (shortness of breath, fatigue, swelling). Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).
Exclusion Criteria:
* -Age \<18 years
* Inability to obtain consent from patient or legally authorized representative
* Active acute or chronic psychiatric illness that in the opinion of the investigator may prevent compliance with study instructions
* Limited English or Spanish proficiency that in the opinion of the investigator may prevent understanding the content of the informed consent form or safely completing the study procedures
* Participation in another concurrent intervention study within 30 days or treatment with an investigational drug within 5 half-lives prior to randomization
* Greater than mild mitral or aortic valve regurgitation/stenosis known pre-cancer therapy
* Severe kidney disease (GFR \<30 mL/min/1.73m2)
* Chronic hyperkalemia (\>5mmol/L)
* Evidence of COVID-19 within the last 60 days or recent (21 days) exposure to close personal contact with COVID-19.
* Greater than moderate tricuspid or pulmonary valve regurgitation/stenosis known pre-cancer therapy
* Hemodynamically significant congenital heart disease in the opinion of the investigator (not including PFO/small ASD or small VSD)
* Greater than moderate pericardial effusion
* Constrictive cardiomyopathy diagnosed pre-cancer therapy
* Family history of genetic cardiomyopathy
* Evidence of infiltrative cardiomyopathy
* Symptomatic heart disease based on NYHA classification
* Allergy to valsartan or sacubitril
* Inability to complete CMR or 6-minute walk test
* Inability to measure non-invasive blood pressure and heart rate in the ambulatory/home setting
* Pregnant/lactating
* History of severe hypersensitivity reactions to gadolinium-based contrast agents (will perform limited cardiac imaging without contrast)
* Concomitant use of other ACE inhibitors or ARBs, aliskiren, NSAIDs or lithium or the inability to stop these medications for the study DRUG: Sacubitril-valsartan, DRUG: Valsartan
Heart Failure, Heart Dysfunction
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 1 location
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Massey CTO CPC Team - (masseycpc@vcu.edu) |
Quality of Pediatric Resuscitation in a Multicenter Collaborative (pediRES-Q)
Vinay Nadkarni, MD, MS - nadkarni@chop.edu
NCT02708134
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Patient received chest compressions for at least 1 minute
* Patient between gestational age ≥37 weeks and 18 years of age
Exclusion Criteria:
* Patient on veno-arterial extracorporeal membrane oxygenation (ECMO) therapy at beginning of CPR event Cardiac Arrest, Cardiopulmonary Arrest
Chest compressions, Cardiopulmonary Resuscitation, Pediatric
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 61 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Aichi Children's Health and Medical Center Aichi, | |
| Akron Children's Akron, Ohio | |
| Albany Medical Center Albany, New York | |
| Alberta Children's Calgary, | |
| All Children's Hospital St. Petersburg, Florida | |
| BC Children's Vancouver, British Columbia | |
| Boston Children's Boston, Massachusetts | |
| Cedars-Sinai Medical Center Los Angeles, California | |
| Children's Colorado Aurora, Colorado | |
| Children's Healthcare of Atlanta (CHOA) Atlanta, Georgia | |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Vinay Nadkarni, MD, MS - (nadkarni@chop.edu) |
| Children's Hospital of Richmond at VCU Richmond, Virginia | |
| Chldren's Hospital of Orange County Orange, California | |
| Cincinnati Children's Hospital Medical Center Cincinnati, Ohio | |
| Cohen Children's Medical Center New Hyde Park, New York | |
| Dartmouth Hitchcock Medical Center Lebanon, New Hampshire | |
| Dell Children's Medical Center Austin, Texas | |
| Erasmus MC - Sophia Children's Rotterdam, | |
| Great Ormond Street Hospital London, | |
| Gregorio Marañón General University Hospital Madrid, | |
| IRCCS Ospedale Pediatrico Bambino Gesu Rome, | |
| Instituto Roosevelt Bogotá, | |
| KK Women's & Children's Hospital Singapore, | |
| Kaiser Permanente Fresno, California | |
| Kentucky Children's Hospital Lexington, Kentucky | |
| King Chulalongkorn University Bangkok, | |
| Kobe Children's Hospital (Hyogo Prefectural) Kobe, | |
| Lurie Children's (Children's Hospital of Chicago) Chicago, Illinois | |
| Massachusetts General Hospital Boston, Massachusetts | |
| Medical City Children's Hospital Dallas, Texas | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical University of South Carolina Charleston, South Carolina | |
| Morgan Stanley Children's Hospital New York, New York | |
| Mount Sinai Kravis Children's Hospital New York, New York | |
| National Taiwan University Hospital Taipei, | |
| National University Hospital Kent Ridge, | |
| Nationwide Children's Hospital Columbus, Ohio | |
| Nebraska Medical Center Omaha, Nebraska | |
| Nemours Children's Hospital Orlando, Florida | |
| Perth Children's Hospital Perth, Western Australia | |
| Queensland Children's Hospital South Brisbane, Queensland | |
| Rady Children's Hospital San Diego, California | |
| Riley Hospital for Children Indianapolis, Indiana | |
| Sabara Hospital Infantil São Paulo, | |
| Seattle Children's Hospital Seattle, Washington | |
| Seoul National University Bundang Hospital Seongnam-si, | |
| St. Louis Children's Hospital St Louis, Missouri | |
| Stanford University Palo Alto, California | |
| Starship Children's Hospital Grafton, Auckland | |
| Stollery Children's Hospital Edmonton, Alberta | |
| Stony Brook University Hospital Stony Brook, New York | |
| The Children's Hospital at Westmead Westmead, New South Wales | |
| The Children's Hospital of San Antonio San Antonio, Texas | |
| The Johns Hopkins Hospital Baltimore, Maryland | |
| Tokyo Metropolitan Children's Medical Center Tokyo, | |
| University of Chicago, Comer Children's Hospital Chicago, Illinois | |
| University of Iowa Stead Family Children's Hospital Iowa City, Iowa | |
| University of North Carolina Chapel Hill, North Carolina | |
| University of Texas Southwestern Dallas, Texas | |
| Upstate Golisano Children's Hospital Syracuse, New York | |
| Valley Children's Hospital Madera, California |
Anticoagulation in ICH Survivors for Stroke Prevention and Recovery (ASPIRE)
Kevin N Sheth, MD - kevin.sheth@yale.edu
NCT03907046
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Age at least 18 years
* Intracerebral hemorrhage (ICH) (including primary intraventricular hemorrhage) confirmed by brain CT or MRI
* Can be randomized within 14-180 days after ICH onset
* Non-valvular AF (defined as atrial fibrillation or atrial flutter), documented by electrocardiography or a physician-confirmed history of prior AF
* Provision of signed and dated informed consent form by patient or legally authorized representative
* For females of reproductive potential: use of highly effective contraception
Exclusion Criteria:
* Index event is hemorrhagic transformation of a brain infarction or hemorrhage into a tumor
* History of earlier ICH within 12 months preceding index event
* Active infective endocarditis
* Clear indication for anticoagulant drugs (e.g., requires anticoagulation for deep vein thrombosis or pulmonary embolism) or antiplatelet drugs (e.g., requires aspirin or clopidogrel for recent coronary stent).
* Previous or planned left atrial appendage closure
* Clinically significant bleeding diathesis
* Serum creatinine ≥2.5 mg/dL
* Active hepatitis or hepatic insufficiency with Child-Pugh score B or C
* Anemia (hemoglobin \<8 g/dL) or thrombocytopenia (\<100 x 10\^9/L) that is chronic in the judgment of the investigator
* Pregnant or breastfeeding
* Known allergy to aspirin or apixaban
* Concomitant participation in a competing trial
* Considered by the investigator to have a condition that precludes safe or active participation in the trial
* Persistent, uncontrolled systolic blood pressure (≥180 mm Hg)
* ICH caused by an arteriovenous malformation (AVM) that has not yet been secured DRUG: Apixaban, DRUG: Aspirin
Intracerebral Hemorrhage, Atrial Fibrillation
I'm interested
Share via email
See this study on ClinicalTrials.gov
Show 181 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Abbott Northwestern Hospital Minneapolis, Minnesota | |
| Arrowhead Regional Medical Center Colton, California | |
| Ascension Sacred Heart Pensacola Pensacola, Florida | |
| Ascension St. John Medical Center Tulsa, Oklahoma | |
| Augusta University Medical Center Augusta, Georgia | |
| Avera Research Institute Sioux Falls, South Dakota | |
| Banner University Medical Center Phoenix, Arizona | |
| Baptist Health Lexington Lexington, Kentucky | |
| Barnes Jewish Hospital St Louis, Missouri | |
| Baylor College of Medicine Medical Center Houston, Texas | |
| Baystate Medical Center Springfield, Massachusetts | |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | |
| Bon Secours St. Mary's Hospital Richmond, Virginia | |
| Boston Medical Center Boston, Massachusetts | |
| Buffalo General Medical Center Buffalo, New York | |
| Capital Health Regional Medical Center Pennington, New Jersey | |
| Carolinas Medical Center Charlotte, North Carolina | |
| Cedars-Sinai Medical Center Los Angeles, California | |
| Central DuPage Hospital Winfield, Illinois | |
| Chandler Regional Medical Center Chandler, Arizona | |
| Cleveland Clinic Cleveland, Ohio | |
| Cleveland Clinic Akron General Akron, Ohio | |
| Cleveland Clinic Tradition Hospital Port Saint Lucie, Florida | |
| Cooperman Barnabas Medical Center West Orange, New Jersey | |
| Cox Medical Center South Springfield, Missouri | |
| Danbury Hospital Danbury, Connecticut | |
| Desert Regional Medical Center Palm Springs, California | |
| Doctors Medical Center Modesto, Modesto, CA Modesto, California | |
| Duke University Hospital Durham, North Carolina | |
| ECU Health Medical Center Greenville, North Carolina | |
| Eastern Maine Medical Center Bangor, Maine | |
| Eden Medical Center, Castro Valley Castro Valley, California | |
| Emory University Hospital Atlanta, Georgia | |
| Erlanger Health System Chattanooga, Tennessee | |
| Evanston Hospital Evanston, Illinois | |
| Forsyth Medical Center Winston-Salem, North Carolina | |
| Fort Sanders Regional Medical Center Knoxville, Tennessee | |
| Froedtert Hospital Milwaukee, Wisconsin | |
| Geisinger Medical Center Danville, Pennsylvania | |
| George Washington University Hospital Washington D.C., District of Columbia | |
| Good Samaritan Hospital Corvallis, Oregon | |
| Grady Memorial Hospital Delaware, Ohio | |
| Greenville Hospital System Greenville, South Carolina | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Harborview Medical Center Seattle, Washington | |
| Hartford Hospital Hartford, Connecticut | |
| HealthPartners Methodist Hospital Saint Louis Park, Minnesota | |
| Henry Ford Hospital Detroit, Michigan | |
| Hoag Hospital Newport Beach Newport Beach, California | |
| Hospital of the University of Pennsylvania Philadelphia, Pennsylvania | |
| Houston Methodist Hospital Houston, Texas | |
| Huntington Memorial Hospital Pasadena, California | |
| IU Health Methodist Hospital Indianapolis, Indiana | |
| Inova Fairfax Hospital Falls Church, Virginia | |
| Jackson Memorial Hospital Miami, Florida | |
| Javon Bea Hospital - Riverside Rockford, Illinois | |
| Jefferson Abington Hospital Abington, Pennsylvania | |
| Kaiser Permanente Fontana Medical Center Fontana, California | |
| Kaiser Permanente Los Angeles Medical Center Los Angeles, California | |
| Kaiser Permanente Redwood City Medical Center, Redwood City, CA Redwood City, California | |
| Kaiser Permanente Sacramento Medical Center Sacramento, California | |
| Kings County Hospital Center Brooklyn, New York | |
| Lahey Hospital & Medical Center Burlington, Massachusetts | |
| Lehigh Valley Hospital - Cedar Crest Allentown, Pennsylvania | |
| Long Beach Memorial Medical Center Long Beach, California | |
| Los Alamitos Medical Center Los Alamitos, California | |
| Loyola University Medical Center Maywood, Illinois | |
| M Health Fairview University of Minnesota Medical Center Minneapolis, Minnesota | |
| Maimonides Medical Center Brooklyn, New York | |
| Maine Medical Center Scarborough, Maine | |
| Massachusetts General Hospital Boston, Massachusetts | |
| Mayo Clinic Rochester, Minnesota | |
| McLaren Flint Flint, Michigan | |
| McLaren Macomb Mount Clemens, Michigan | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical University of South Carolina University Hospital Charleston, South Carolina | |
| Medstar Washington Hospital Center Washington D.C., District of Columbia | |
| Memorial Hermann Texas Medical Center Houston, Texas | |
| Mercy Hospital Oklahoma City Oklahoma City, Oklahoma | |
| Mercy Hospital South St Louis, Missouri | |
| Mercy Hospital Springfield Springfield, Missouri | |
| Mercy Hospital St. Louis St Louis, Missouri | |
| Mercy San Juan Medical Center Carmichael, California | |
| Methodist University Hospital Memphis, Tennessee | |
| Metro Health Hospital Wyoming, Michigan | |
| MetroHealth Medical Center Cleveland, Ohio | |
| Montefiore Medical Center The Bronx, New York | |
| Morton Plant Hospital Clearwater, Florida | |
| Moses H. Cone Memorial Hospital Greensboro, North Carolina | |
| Mount Sinai West New York, New York | |
| Munson Medical Center Traverse City, Michigan | |
| NCH Hospital, Arlington Heights Arlington Heights, Illinois | |
| NYC Health + Hospitals/Elmhurst Elmhurst, New York | |
| NYP Columbia University Medical Center New York, New York | |
| NYP Weill Cornell Medical Center New York, New York | |
| NYU Langone Hospital - Brooklyn Brooklyn, New York | |
| New Hanover Regional Medical Center Wilmington, North Carolina | |
| NewYork-Presbyterian Brooklyn Methodist Hospital Brooklyn, New York | |
| North Shore University Hospital Manhasset, New York | |
| OSF St. Francis Medical Center Peoria, Illinois | |
| OSU Wexner Medical Center Columbus, Ohio | |
| OU Medical Center Oklahoma City, Oklahoma | |
| Ochsner Medical Center - Main Campus New Orleans, Louisiana | |
| Oregon Health & Science University Hospital Portland, Oregon | |
| Overlook Medical Center Summit, New Jersey | |
| PIH Health Hospital - Whittier Whittier, California | |
| PeaceHealth Sacred Heart Medical Center - RiverBend Springfield, Oregon | |
| Penn State Hershey Medical Center Hershey, Pennsylvania | |
| Presbyterian Medical Center Philadelphia, Pennsylvania | |
| Providence St. Vincent Medical Center Portland, Oregon | |
| Rancho Los Amigos National Rehabilitation Center Downey, California | |
| Regions Hospital Saint Paul, Minnesota | |
| Rhode Island Hospital Providence, Rhode Island | |
| Riverside Methodist Hospital Columbus, Ohio | |
| Ronald Reagan UCLA Medical Center Los Angeles, California | |
| Rush University Medical Center Chicago, Illinois | |
| SUNY Upstate Medical University Syracuse, New York | |
| Saint Alphonsus Regional Medical Center - Boise Boise, Idaho | |
| San Francisco General Hospital San Francisco, California | |
| Santa Barbara Cottage Hospital Santa Barbara, California | |
| Semmes Murphey Main Campus Memphis, Tennessee | |
| St. Cloud Hospital Saint Cloud, Minnesota | |
| St. David's Medical Center Austin, Texas | |
| St. John Medical Center Tulsa, Oklahoma | |
| St. John's Hospital Springfield, Illinois | |
| St. Joseph's Hospital Tampa, Florida | |
| St. Joseph's Hospital and Medical Center Phoenix, Arizona | |
| St. Jude Medical Center Fullerton, California | |
| St. Mary's Medical Center Grand Junction, Colorado | |
| Stanford University Medical Center Palo Alto, California | |
| Staten Island University Hospital - North Campus Staten Island, New York | |
| Stony Brook University Hospital Stony Brook, New York | |
| Strong Memorial Hospital Rochester, New York | |
| Swedish Medical Center - Cherry Hill Campus Seattle, Washington | |
| Tampa General Hospital Tampa, Florida | |
| Temple University Hospital Philadelphia, Pennsylvania | |
| The Mount Sinai Hospital New York, New York | |
| The Queen's Medical Center Honolulu, Hawaii | |
| The University of Vermont Medical Center Burlington, Vermont | |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | |
| Trinity Health Saint Mary's Grand Rapids, Michigan | |
| Trinity Health Saint Mary's Grand Rapids, Michigan | |
| Tufts Medical Center Boston, Massachusetts | |
| UAMS Medical Center Little Rock, Arkansas | |
| UC Davis Medical Center Sacramento, California | |
| UC Irvine Medical Center Orange, California | |
| UF Health Jacksonville Jacksonville, Florida | |
| UH Cleveland Medical Center Cleveland, Ohio | |
| UMass Memorial Medical Center Worcester, Massachusetts | |
| UPMC Presbyterian Hospital Pittsburgh, Pennsylvania | |
| UT Southwestern Medical Center Dallas, Texas | |
| UVA Medical Center Charlottesville, Virginia | |
| United Hospital, St. Paul Saint Paul, Minnesota | |
| University of Alabama Hospital Birmingham, Alabama | |
| University of Chicago Medical Center Chicago, Illinois | |
| University of Chicago Medical Center Chicago, Illinois | |
| University of Cincinnati Medical Center Cincinnati, Ohio | |
| University of Colorado Hospital Aurora, Colorado | |
| University of Illinois Hospital Chicago, Illinois | |
| University of Iowa Medical Center Iowa City, Iowa | |
| University of Kansas Hospital Kansas City, Kansas | |
| University of Kentucky Hospital Lexington, Kentucky | |
| University of Louisville Hospital Louisville, Kentucky | |
| University of Michigan University Hospital Ann Arbor, Michigan | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Missouri Health Care Columbia, Missouri | |
| University of Nebraska Medical Center Omaha, Nebraska | |
| University of New Mexico Hospital Albuquerque, New Mexico | |
| University of North Carolina Medical Center Chapel Hill, North Carolina | |
| University of South Alabama University Hospital Mobile, Alabama | |
| University of Texas Health Science Center San Antonio San Antonio, Texas | |
| University of Utah Healthcare Salt Lake City, Utah | |
| VCU Medical Center Richmond, Virginia | |
| Vanderbilt University Hospital Nashville, Tennessee | |
| Vassar Brothers Medical Center Poughkeepsie, New York | |
| Virginia Mason Medical Center Seattle, Washington | |
| WVU Healthcare Ruby Memorial Hospital Morgantown, West Virginia | |
| Wake Forest Baptist Medical Center Winston-Salem, North Carolina | |
| Wellstar Kennestone Hospital Marietta, Georgia | |
| Westchester Medical Center Valhalla, New York | |
| Yale New Haven Hospital New Haven, Connecticut |
EXercise Cardiac Magnetic Resonance Assessment of Left Atrial Mechanics Following Ablation (EXCLAMATORY)
Pamela Grizzard - pamela.grizzard@vcuhealth.org
NCT06212791
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Age ≥18 years
* Diagnosis of paroxysmal AF
* Left ventricular ejection fraction ≥50%
* Scheduled for catheter ablation
* Able to speak, hear, and read English
* Willing and able to provide informed consent
Exclusion Criteria:
* Persistent or permanent AF
* Prior ablation (catheter based or surgical) for AF
* Significant sinus node dysfunction
* Implanted pacemaker or defibrillator
* Contraindication to or inability to complete cardiovascular magnetic resonance study
* Contraindication to or inability to complete exercise testing
* Chronic kidney disease with estimated glomerular filtration rate \<30 mL/min/1.73m2
* Severe left ventricular hypertrophy
* Unrelated cardiomyopathy that is expected to limit exercise capacity, including but not limited to:
* Hypertrophic cardiomyopathy
* Cardiac amyloidosis
* Constrictive pericarditis
* Pulmonary arterial hypertension
* Prior cardiac surgery
* Active pregnancy BEHAVIORAL: Self- Report Evaluation-Duke Activity Status Index, BEHAVIORAL: Self- Report Evaluation Atrial Fibrillation Effect on Quality of Life Questionnaire, DIAGNOSTIC_TEST: Cardiopulmonary exercise test (CPET), DIAGNOSTIC_TEST: Transthoracic echocardiogram, DIAGNOSTIC_TEST: Ambulatory cardiac rhythm assessment, DIAGNOSTIC_TEST: Cardiovascular magnetic resonance (CMR)
Paroxysmal Atrial Fibrillation
Catheter ablation, Exercise capacity
I'm interested
Share via email
Show 1 location
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Pamela Grizzard - (pamela.grizzard@vcuhealth.org) Melissa Sears - (melissa.sears@vcuhealth.org) |
A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF) (OMNY-AF)
Study Contact - rshar120@its.jnj.com
NCT06455098
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Diagnosed with symptomatic paroxysmal AF with:
• At least two symptomatic AF episodes within last six months from enrollment
• At least one electrocardiographically documented AF episode within twelve months prior to enrollment * Failed at least one Class I or Class III antiarrhythmic drug * Willing and capable to provide consent * Able and willing to comply with all pre-, post- and follow-up testing and requirements
Exclusion Criteria:
* Previously diagnosed with persistent AF (greater than \[\>\] 7 days in duration)
* AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
* Previous surgical or catheter ablation for AF
* Patients known to require ablation outside the PV ostia and outside the CTI region.
* Documented severe dilatation of the left atrium (LAD\>50 mm) antero-posterior diameter on imaging within 6 months prior to enrollment
* Documented left atrium (LA) thrombus by imaging within 48 hours of the procedure
* Documented severely compromised left ventricular ejection fraction (LVEF \<40%) by imaging within 6 months prior to enrollment
* Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
* History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
* Documented thromboembolic event (including transient ischemic attack or TIA) within the past 6 months
* Previous Percutaneous Coronary Intervention (PCI)/ myocardial infarction \[MI\] within the past 2 months
* Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months
* Valvular cardiac surgical/percutaneous procedure
* Unstable angina within 6 months
* Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
* Significant pulmonary disease or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
* Prior diagnosis of pulmonary vein stenosis
* Pre-existing hemi diaphragmatic paralysis
* Acute illness, active systemic infection, or sepsis
* Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
* Severe mitral regurgitation
* Presence of an implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device (other than coronary stents) that may interfere with the PF energy field)
* Presence of a condition that precludes vascular access
* Current enrollment in an investigational study evaluating another device or drug
* Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation
* Life expectancy less than 12 months
* Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions for Use (IFU) DEVICE: OMNYPULSE™ Catheter with the TRUPULSE Generator
Atrial Fibrillation
I'm interested
Share via email
Show 46 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Advent Health Orlando Orlando, Florida | |
| Ascension St. Vincent's Jacksonville, Florida | |
| Baptist Health Research Institute Jacksonville, Florida | |
| Beaumont Health Systems Royal Oak, Michigan | |
| Brigham and Women's Hospital Boston, Massachusetts | |
| California Pacific Medical Center- Sutter Health San Francisco, California | |
| Canberra Heart Rhythm Garran, | |
| Cardiovascular Associates of Marin Larkspur, California | |
| Cleveland Clinic Cleveland, Ohio | |
| Emory Saint Joseph's Hospital Atlanta, Georgia | |
| HCA Florida Mercy Hospital Miami, Florida | |
| Hartford Hospital Hartford, Connecticut | |
| Hoag Memorial Hospital Newport Beach, California | |
| Inova Fairfax Medical Campus- Inova Heart and Vascular Institute Falls Church, Virginia | |
| Intermountain Medical Center Murray, Utah | |
| Johns Hopkins Baltimore, Maryland | |
| Lenox Hill Hospital New York, New York | |
| Loma Linda Medical Center Loma Linda, California | |
| Massachusetts General Boston, Massachusetts | |
| Memorial Health University Medical Center Savannah, Georgia | |
| Mills Peninsula Health Services Burlingame, California | |
| Minneapolis Heart Institute Minneapolis, Minnesota | |
| Montefiore Medical Center The Bronx, New York | |
| Morristown Medical Center Morristown, New Jersey | |
| Mount Sinai School of Medicine New York, New York | |
| NCH Healthcare Naples, Florida | |
| New Mexico Heart Institute Albuquerque, New Mexico | |
| New York Presbyterian - Weill Cornell Medical Ctr New York, New York | |
| NorthShore University Medical Center Glenview, Illinois | |
| Northside Hospital Atlanta, Georgia | |
| Phoenix Cardiovascular Research Group Phoenix, Arizona | |
| Piedmont Healthcare Atlanta, Georgia | |
| Providence Saint John s Health Center Santa Monica, California | |
| Royal Adelaide Hospital Adelaide, | |
| Royal Melbourne Hospital Parkville, | |
| San Diego Cardiac Center San Diego, California | |
| Scripps Clinic/Prebys Cardiovascular Institute La Jolla, California | |
| Sentara Norfolk General Hospital Norfolk, Virginia | |
| St Francis Hospital Roslyn, New York | |
| Texas Cardiac Arrhythmia Research Foundation Austin, Texas | |
| Texas Heart Institute Houston, Texas | |
| University of Colorado Aurora, Colorado | |
| University of Pennsylvania Health System Philadelphia, Pennsylvania | |
| Virginia Commonwealth University Richmond, Virginia | |
| WakeMed Heart & Vascular Raleigh, North Carolina | |
| York Hospital York Village, Maine |
Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure (DRAIN-HF)
Rubi Reyes-Fuentez - rubi@procyrion.com
NCT05677100
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria (Randomized Study):
* Currently admitted to the hospital with a primary diagnosis of decompensated heart failure, irrespective of ejection fraction (EF);
* Patients should be on maximally tolerated diuretic therapy and not diuresing sufficiently before being enrolled in DRAIN-HF. After being up-titrated on diuretics, patients should be followed for at least 24 hours on the higher of: i) furosemide 80 mg IV bid or equivalent or ii) IV furosemide or equivalent IV loop diuretic at a dose 2.5 x total daily home dose of furosemide equivalents in 2 divided doses, as tolerated, patient must have: Urine Output \<1,500mL in a 12-hour period OR a Net Fluid Loss ≤375mL in a 12-hour period.
* Persistent signs and/or symptoms of congestion as evidenced by at least 2+ pitting edema, elevated jugular venous pressure \>12 cm water or ascites after treatment with IV diuretics per inclusion criterion 2.;
* Age \>21 years and able to provide written informed consent;
* Negative pregnancy test if patient is of child-bearing potential.
Exclusion Criteria (Randomized Study):
* Treatment with high dose IV inotropes within the last 48 hours prior to enrollment. High dose is defined as \>5 µg/kg/min dopamine OR \>5 µg/kg/min dobutamine OR \>0.375 µg/kg/min milrinone;
* Active and ongoing hypotension with a systolic blood pressure \<90 mmHg lasting more than 30 minutes or a mean arterial pressure (MAP) \<60 mmHg lasting more than 30 minutes at enrollment;
* Treatment with vasopressors (defined as phenylephrine, norepinephrine, epinephrine or, vasopressin) within 48 hours prior to enrollment;
* An estimated PASP of \>80 mmHg as measured on echocardiogram or echocardiographic evidence of primarily right heart failure;
* Treatment with IV diuretics (does not have to be continuous) for ≥21 days during the current hospitalization (including time spent at an outside hospital);
* Acute kidney failure defined as an increase in serum creatinine to ≥4.0mg/dL (≥353.6 µmol/L) at enrollment;
* Evidence of contrast induced nephropathy, nephritis or nephrotic syndrome;
* Prior kidney transplant, single kidney, partial nephrectomy OR use of dialysis, continuous renal replacement therapy (CRRT) or ultrafiltration in the last 90 days prior to enrollment;
* Confirmed decompensated cirrhosis (defined as Child Pugh class B or C) or concern for shock liver (AST \> 1000U/L or total Bilirubin \> 5.0mg/dl) at enrollment;
* Presence of an active, uncontrolled infection that would preclude safe placement or removal of the device;
* Prior heart transplant or likely heart transplantation before the 30- day follow-up visit;
* Current or previous support with a durable LVAD at any time or planned LVAD insertion before the 30-day follow-up visit;
* Use of an intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO), or percutaneous ventricular assist devices (e.g. Impella or TandemHeart) within the last 30 days;
* Known amyloidosis of any type;
* Acute myocardial infarction Type 1 within 30 days of enrollment, or planned coronary revascularization in the next 30 days;
* Stroke within 30 days of enrollment;
* Severe Bleeding Risk (any of the following):
• Previous intracranial bleed unless there is documentation in the medical record (from a physician that is not part of the study) that the patient can safely use anticoagulation for 7 days,
• GI bleeding within 6 months requiring hospitalization and/or transfusion,
• Recent major surgery within 30 days if the surgical wound is judged to be associated with an increased risk of bleeding,
• Procedure with arterial ilio-femoral access \> 6 FR within 30 days,
• Platelet count \<75,000 cells/mm3,
• Uncorrectable bleeding diathesis or coagulopathy (e.g. INR ≥2 not due to anticoagulation therapy) or hypercoaguable state including HIT;
• Inability to tolerate anticoagulation therapy for up to 7 days. * Contraindicated Anatomy :
• Descending aortic anatomy that would prevent safe placement of the device \[\<18 mm or \>31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)\],
• Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21F (outer diameter) introducer sheath,
• Femoral artery depth inconsistent with use of closure device,
• Abnormalities or severe vascular disease that would preclude safe access and device delivery (e.g. aneurysm with thrombus, marked tortuosity, significant narrowing or inadequate size of the abdominal aorta, iliac or femoral arteries, or severe calcification),
• Known connective tissue disorder (e.g. Marfan Syndrome) or other aortopathy at risk of vascular injury,
• Any endovascular stent graft in the descending aorta. Any endovascular stent graft in the femoro-iliac vessels that is not well endothelialized and would preclude safe introduction/removal of the Aortix pump as demonstrated by imaging. * Known hypersensitivity or contraindication to study or procedure medications (e.g. anticoagulation therapy) or device materials (e.g. history of severe reaction to nickel or nitinol); * Participation in any other clinical investigation that is likely to confound study results or affect the study; * Poor health such that the patient is unable to undergo the Aortix device placement/retrieval and/or unlikely to be able to survive to the 30-day visit; * Unable or unwilling to undergo screening (imaging, PA Catheter placement), device implant and retrieval procedures or return for 30-day visit. Inclusion Criteria (Advanced Heart Failure Registry): * Currently admitted to the hospital with a primary diagnosis of decompensated HF, irrespective of ejection fraction (EF). * Patient has already been evaluated and indicated to receive an LVAD or heart transplant and will receive the LVAD or be listed for heart transplantation in the next 30 days if their congestion status and renal function improves. * Patient must have been treated with ≥ 80 mg IV furosemide bid or equivalent and have evidence of increasing diuretic dosing requirements over the past 12 months, as tolerated. * Must have evidence of refractoriness to medical management as documented by persistent signs and/or symptoms of congestion as evidenced by at least 2+ pitting edema, elevated jugular venous pressure \>12 cm water, or ascites after treatment with IV diuretics for a minimum of 24 hours. * Serum creatinine ≥ 2.0 mg/dL AND eGFR ≤ 45 ml/min/1.73m2 at time of enrollment * Age ≥ 21 years and able to provide written informed consent. * Negative pregnancy test if patient is of childbearing potential. Exclusion Criteria (Advanced Heart Failure Registry): * Treatment with high dose IV inotropes within 48 hours prior to enrollment. High dose is defined as any one of the following: \>5 µg/kg/min dopamine OR \>5 µg/kg/min dobutamine OR \>0.375 µg/kg/min milrinone. * Active and ongoing hypotension with a systolic blood pressure \<80 mmHg lasting more than 30 minutes or a mean arterial pressure (MAP) \<55 mmHg lasting more than 30 minutes at enrollment. * Treatment with vasopressors (defined as phenylephrine, norepinephrine, epinephrine or, vasopressin) within 48 hours prior to enrollment. * An estimated PASP of \>80 mmHg as measured on echocardiogram or echocardiographic evidence of primarily right heart failure. * Acute kidney failure defined as an increase in serum creatinine to ≥ 4.0mg/dL at enrollment. * Evidence of contrast-induced nephropathy, nephritis, or nephrotic syndrome. * Prior kidney transplant, single kidney, partial nephrectomy OR use of dialysis, continuous renal replacement therapy (CRRT), or ultrafiltration in the last 90 days prior to enrollment. * Confirmed decompensated cirrhosis (defined as Child Pugh class B or C) or concern for shock liver (AST \> 1000U/L or total Bilirubin \> 5.0mg/dl) at enrollment. * Presence of an active, uncontrolled infection that would preclude safe placement or removal of the device. * Current or previous support with a durable LVAD. * INTERMACS Profile 1 at enrollment. * Currently on mechanical ventilatory support. * Use of an intra-aortic balloon pump (IABP) within the last 14 days or use of an extracorporeal membrane oxygenation (ECMO) or percutaneous ventricular assist device (e.g., Impella or TandemHeart) within the last 30 days. * Known amyloidosis of any type. * Acute myocardial infarction Type 1 within 30 days of enrollment or planned coronary revascularization in the next 30 days. * Stroke within 30 days of enrollment. * Severe Bleeding Risk (any of the following): * Previous intracranial bleed unless there is documentation in the medical record (from a physician that is not part of the study) that the patient can safely use anticoagulation for 7 days. * GI bleeding within 6 months requiring hospitalization and/or transfusion. * Recent major surgery within 30 days if the surgical wound is judged to be associated with an increased risk of bleeding. * Procedure with arterial ilio-femoral access \> 6 Fr within 30 days. * Platelet count \<75,000 cells/mm3 . * Uncorrectable bleeding diathesis or coagulopathy (e.g., INR≥ 2 not due to anticoagulation therapy) or hypercoagulable state including HIT. * Inability to tolerate anticoagulation therapy for up to 7 days. * Contraindicated Anatomy : * Descending aortic anatomy that would prevent safe placement of the device \[\<18 mm or \>31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)\]. * Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21 Fr (outer diameter) introducer sheath. * Femoral artery depth inconsistent with use of closure device. * Abnormalities or severe vascular disease that would preclude safe access and device delivery (e.g., aneurysm with thrombus; marked tortuosity; significant narrowing or inadequate size of the abdominal aorta, iliac, or femoral arteries; or severe calcification). * Known connective tissue disorder (e.g., Marfan Syndrome) or other aortopathy at risk of vascular injury. * Any endovascular stent graft in the descending aorta. Any endovascular stent graft in the femoro-iliac vessels that is not well endothelialized and would preclude safe introduction/removal of the Aortix pump as demonstrated by imaging. * Known hypersensitivity or contraindication to study or procedure medications (e.g., anticoagulation therapy) or device materials (e.g., history of severe reaction to nickel or nitinol). * Participation in any other clinical investigation that is likely to confound study results or affect the study. * Poor health such that the patient is unable to undergo the Aortix device placement/retrieval and/or unlikely to be able to survive to the 30-day visit. * Unable or unwilling to undergo screening, device implant and retrieval procedures, or return for 30-day visit.
• Previous intracranial bleed unless there is documentation in the medical record (from a physician that is not part of the study) that the patient can safely use anticoagulation for 7 days,
• GI bleeding within 6 months requiring hospitalization and/or transfusion,
• Recent major surgery within 30 days if the surgical wound is judged to be associated with an increased risk of bleeding,
• Procedure with arterial ilio-femoral access \> 6 FR within 30 days,
• Platelet count \<75,000 cells/mm3,
• Uncorrectable bleeding diathesis or coagulopathy (e.g. INR ≥2 not due to anticoagulation therapy) or hypercoaguable state including HIT;
• Inability to tolerate anticoagulation therapy for up to 7 days. * Contraindicated Anatomy :
• Descending aortic anatomy that would prevent safe placement of the device \[\<18 mm or \>31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)\],
• Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21F (outer diameter) introducer sheath,
• Femoral artery depth inconsistent with use of closure device,
• Abnormalities or severe vascular disease that would preclude safe access and device delivery (e.g. aneurysm with thrombus, marked tortuosity, significant narrowing or inadequate size of the abdominal aorta, iliac or femoral arteries, or severe calcification),
• Known connective tissue disorder (e.g. Marfan Syndrome) or other aortopathy at risk of vascular injury,
• Any endovascular stent graft in the descending aorta. Any endovascular stent graft in the femoro-iliac vessels that is not well endothelialized and would preclude safe introduction/removal of the Aortix pump as demonstrated by imaging. * Known hypersensitivity or contraindication to study or procedure medications (e.g. anticoagulation therapy) or device materials (e.g. history of severe reaction to nickel or nitinol); * Participation in any other clinical investigation that is likely to confound study results or affect the study; * Poor health such that the patient is unable to undergo the Aortix device placement/retrieval and/or unlikely to be able to survive to the 30-day visit; * Unable or unwilling to undergo screening (imaging, PA Catheter placement), device implant and retrieval procedures or return for 30-day visit. Inclusion Criteria (Advanced Heart Failure Registry): * Currently admitted to the hospital with a primary diagnosis of decompensated HF, irrespective of ejection fraction (EF). * Patient has already been evaluated and indicated to receive an LVAD or heart transplant and will receive the LVAD or be listed for heart transplantation in the next 30 days if their congestion status and renal function improves. * Patient must have been treated with ≥ 80 mg IV furosemide bid or equivalent and have evidence of increasing diuretic dosing requirements over the past 12 months, as tolerated. * Must have evidence of refractoriness to medical management as documented by persistent signs and/or symptoms of congestion as evidenced by at least 2+ pitting edema, elevated jugular venous pressure \>12 cm water, or ascites after treatment with IV diuretics for a minimum of 24 hours. * Serum creatinine ≥ 2.0 mg/dL AND eGFR ≤ 45 ml/min/1.73m2 at time of enrollment * Age ≥ 21 years and able to provide written informed consent. * Negative pregnancy test if patient is of childbearing potential. Exclusion Criteria (Advanced Heart Failure Registry): * Treatment with high dose IV inotropes within 48 hours prior to enrollment. High dose is defined as any one of the following: \>5 µg/kg/min dopamine OR \>5 µg/kg/min dobutamine OR \>0.375 µg/kg/min milrinone. * Active and ongoing hypotension with a systolic blood pressure \<80 mmHg lasting more than 30 minutes or a mean arterial pressure (MAP) \<55 mmHg lasting more than 30 minutes at enrollment. * Treatment with vasopressors (defined as phenylephrine, norepinephrine, epinephrine or, vasopressin) within 48 hours prior to enrollment. * An estimated PASP of \>80 mmHg as measured on echocardiogram or echocardiographic evidence of primarily right heart failure. * Acute kidney failure defined as an increase in serum creatinine to ≥ 4.0mg/dL at enrollment. * Evidence of contrast-induced nephropathy, nephritis, or nephrotic syndrome. * Prior kidney transplant, single kidney, partial nephrectomy OR use of dialysis, continuous renal replacement therapy (CRRT), or ultrafiltration in the last 90 days prior to enrollment. * Confirmed decompensated cirrhosis (defined as Child Pugh class B or C) or concern for shock liver (AST \> 1000U/L or total Bilirubin \> 5.0mg/dl) at enrollment. * Presence of an active, uncontrolled infection that would preclude safe placement or removal of the device. * Current or previous support with a durable LVAD. * INTERMACS Profile 1 at enrollment. * Currently on mechanical ventilatory support. * Use of an intra-aortic balloon pump (IABP) within the last 14 days or use of an extracorporeal membrane oxygenation (ECMO) or percutaneous ventricular assist device (e.g., Impella or TandemHeart) within the last 30 days. * Known amyloidosis of any type. * Acute myocardial infarction Type 1 within 30 days of enrollment or planned coronary revascularization in the next 30 days. * Stroke within 30 days of enrollment. * Severe Bleeding Risk (any of the following): * Previous intracranial bleed unless there is documentation in the medical record (from a physician that is not part of the study) that the patient can safely use anticoagulation for 7 days. * GI bleeding within 6 months requiring hospitalization and/or transfusion. * Recent major surgery within 30 days if the surgical wound is judged to be associated with an increased risk of bleeding. * Procedure with arterial ilio-femoral access \> 6 Fr within 30 days. * Platelet count \<75,000 cells/mm3 . * Uncorrectable bleeding diathesis or coagulopathy (e.g., INR≥ 2 not due to anticoagulation therapy) or hypercoagulable state including HIT. * Inability to tolerate anticoagulation therapy for up to 7 days. * Contraindicated Anatomy : * Descending aortic anatomy that would prevent safe placement of the device \[\<18 mm or \>31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)\]. * Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21 Fr (outer diameter) introducer sheath. * Femoral artery depth inconsistent with use of closure device. * Abnormalities or severe vascular disease that would preclude safe access and device delivery (e.g., aneurysm with thrombus; marked tortuosity; significant narrowing or inadequate size of the abdominal aorta, iliac, or femoral arteries; or severe calcification). * Known connective tissue disorder (e.g., Marfan Syndrome) or other aortopathy at risk of vascular injury. * Any endovascular stent graft in the descending aorta. Any endovascular stent graft in the femoro-iliac vessels that is not well endothelialized and would preclude safe introduction/removal of the Aortix pump as demonstrated by imaging. * Known hypersensitivity or contraindication to study or procedure medications (e.g., anticoagulation therapy) or device materials (e.g., history of severe reaction to nickel or nitinol). * Participation in any other clinical investigation that is likely to confound study results or affect the study. * Poor health such that the patient is unable to undergo the Aortix device placement/retrieval and/or unlikely to be able to survive to the 30-day visit. * Unable or unwilling to undergo screening, device implant and retrieval procedures, or return for 30-day visit.
DEVICE: Aortix System
Heart Failure, Cardiorenal Syndrome, Cardio-Renal Syndrome, ADHF, Heart Failure, Systolic, Heart Failure, Diastolic, Heart Failure, With Decompensation, Heart Failure, Congestive
mechanical circulatory support, percutaneous
I'm interested
Share via email
Show 47 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| AdventHealth Tampa Tampa, Florida | |
| Advocate Aurora - Good Samaritan Downers Grove, Illinois | |
| Advocate IMMC Chicago, Illinois | |
| Ascension Sacred Heart Pensacola, Florida | |
| Ascension via Christi Kansas Wichita, Kansas | |
| Atrium Health Sanger Heart and Vascular Institute Charlotte, North Carolina | Zaida Roman - (Zaida.Roman@advocatehealth.org) |
| Banner--University Medical Center Phoenix Phoenix, Arizona | |
| BayCare Medical/St. Joseph's Hospital Tampa, Florida | |
| Baylor Scott & White Plano, Texas | |
| Baylor Scott & White Research Institute Dallas, Texas | |
| Cleveland Clinic Florida Weston, Florida | |
| Duke University Medical Center Durham, North Carolina | |
| Emory University Hospital Atlanta, Georgia | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Henry Ford Detroit, Michigan | |
| HonorHealth Medical Center Scottsdale, Arizona | |
| Intermountain Health Murray, Utah | |
| Jefferson Abington Hospital Abington, Pennsylvania | |
| Jersey Shore University Medical Center Neptune City, New Jersey | |
| John Muir Health Concord, California | |
| Mayo Clinic - Arizona Phoenix, Arizona | Alexandra Gaughan, R.N. - (Gaughan.Alexandra@mayo.edu) |
| Mount Sinai Morningside New York, New York | |
| New York Presbyterian - Brooklyn Methodist Hospital Brooklyn, New York | Jhane Phanor - (jhp4004@nyp.org) |
| Northwell Health (Lenox Hill) New York, New York | |
| Northwell Health (Staten Island) Staten Island, New York | |
| Novant Health New Hanover Regional Medical Center Wilmington, North Carolina | |
| Nuvance Health Poughkeepsie, New York | |
| Nyph/Cumc New York, New York | |
| Oklahoma Cardiovascular Research Group Oklahoma City, Oklahoma | |
| Oregon Health & Sciences University Portland, Oregon | |
| Penn Presbyterian Medical Center Philadelphia, Pennsylvania | |
| Piedmont Healthcare INC. Augusta, Georgia | |
| San Francisco Veterans Administration San Francisco, California | |
| Semmelweis University Budapest, | Laura Kosa-Hobor - (hobor.laura@semmelweis.hu) |
| Tallahassee Research Institute Tallahassee, Florida | |
| Texas Heart Institute Houston, Texas | |
| The Ohio State University Columbus, Ohio | |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | |
| University of California San Francisco San Francisco, California | |
| University of Chicago Chicago, Illinois | |
| University of Michigan, Cardiovascular Medicine Ann Arbor, Michigan | |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of South Florida Tampa, Florida | |
| University of Virginia Charlottesville, Virginia | |
| Virginia Commonwealth University Richmond, Virginia | |
| Wellstar Research Institue Marietta, Georgia | |
| Zuckerberg San Francisco General San Francisco, California |
A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation (HERMES)
Novo Nordisk - clinicaltrials@novonordisk.com
NCT05636176
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Serum high-sensitivity C-reactive protein (hs-CRP) greater than equal to 2 milligrams per liter (mg/L) at screening (visit 1) Disease specific - cardiovascular
* At least one of the following:
• N-terminal-pro-brain natriuretic peptide (NT-proBNP) greater than equal to 300 picograms per milliliter (pg/mL) at screening (Visit 1) for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NTproBNP must be greater than equal to 600 pg/mL. Note that the screening electrocardiogram (ECG) must be obtained the same day as sampling for NT-proBNP.
• Hospitalisation or urgent/unplanned visit with a primary diagnosis of decompensated heart failure which required intravenous loop diuretic treatment, within the last 9 months prior to screening (visit 1) in combination with NT-proBNP greater than equal to 200 pg/mL at screening (Visit 1) for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NT-proBNP must be greater than equal to 600 pg/mL. * Diagnosis of heart failure (New York Heart Association \[classification\] \[NYHA\] Class II-IV). * Left ventricular ejection fraction (LVEF) greater than 40 percentage (%) documented by echocardiography within 12 months prior to or at screening (visit 1). The LVEF must be documented in medical records and the most recent measurement must be used to determine eligibility with no interim event signalling potential deterioration in ejection fraction (e.g., myocardial infarction \[MI\] or heart failure \[HF\] hospitalisation). * Structural heart disease and/or functional heart disease documented by echocardiography within 12 months prior to or at screening (visit 1) showing at least one of the following: * Left atrial (LA) volume index greater than 34 milliliter per meter square (mL/m\^2). * LA diameter greater than equal to 3.8 centimeter (cm). * LA length greater than equal to 5.0 cm. * LA area greater than equal to 20 cm square. * LA volume greater than equal to 55 milliters (mL). * Intraventricular septal thickness greater than equal to 1.1 cm. * Posterior wall thickness greater than equal to 1.1 cm. * Left ventricular (LV) mass index greater than equal to 115 grams per meter square (g⁄m\^2 ) in men or greater than equal to 95 g⁄m\^2 in women. * E/e' (mean septal and lateral) greater than equal to 10. * e' (mean septal and lateral) less than 9 centimeter per second (cm/s). * No heart failure hospitalisations or urgent heart failure visits between screening (visit 1) and randomisation (visit 2).
Exclusion Criteria:
Medical conditions - cardiovascular
* Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart failure hospitalisation, within 30 days prior to screening (visit 1).
* Systolic blood pressure greater than equal to 180 millimeters of mercury (mmHg) at screening (visit 1). If the systolic blood pressure is 160-179 mmHg, the patient should be receiving greater than equal to 3 antihypertensive drugs. (Note: Potential participants may be retested for this criterion within the visit window and without rescreening, at the discretion of the investigator).
* Heart rate above 110 or below 40 beats per minute as evaluated on the electrocardiogram (ECG) performed at screening (visit 1) (Note: Potential participants may be retested for this criterion within the visit window and without rescreening, at the discretion of the investigator).
* Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1). (Note: Planned coronary angiogram is not exclusionary).
* Planned cardiac device or atrial flutter/atrial fibrillation ablation procedure known during the screening period (visit 1).
* Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomisation (visit 2) or any major surgical procedure planned at the time of randomisation (visit 2).
* Heart failure due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, uncorrected more than moderate primary valve disease.
* Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD.
* Any other condition judged by the investigator that could account for heart failure symptoms and signs (e.g., anaemia, hypothyroidism).
Medical conditions - infections/immunosuppression
\- Clinical evidence of, or suspicion of, active infection at the discretion of the investigator. DRUG: Ziltivekimab, DRUG: Placebo
Heart Failure
I'm interested
Share via email
Show 1075 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| "AHEPA" University General Hospital of Thessaloniki Thessaloniki, | |
| "AHEPA" University General Hospital of Thessaloniki Thessaloniki, | |
| "AHEPA" University General Hospital of Thessaloniki Thessaloniki, | |
| "Carol Davila" Military Emergency Hospital Bucharest, | |
| "Carol Davila" Military Emergency Hospital Bucharest, | |
| "Hygeia" General Hospital of Athens Athens, | |
| "Hygeia" General Hospital of Athens Athens, | |
| "MHAT - UniHospital" OOD Panagyurishte, | |
| "MHAT - UniHospital" OOD Panagyurishte, | |
| "Medical center Medconsult Pleven" OOD Pleven, | |
| "Medical center Zara-Med" EOOD Stara Zagora, | |
| "Sotiria" Thoracic Diseases Hospital of Athens Athens, | |
| "UMHAT Plovdiv" AD Plovdiv, | |
| 'G. Gennimatas' General Hospital of Athens Athens, | |
| 'Ippokrateio' General Hospital of Thessaloniki Thessaloniki, | |
| 'MHAT Sveta Karidad' EAD Plovdiv, | |
| 'Medical Center Hipokrena' EOOD Sevlievo, | |
| 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu Wroclaw, Lower Silesian Voivodeship | |
| A.O.U. Ferrara, Sant'Anna Cona (Ferrara), Fe | |
| A.O.U. Ferrara, Sant'Anna Cona (Ferrara), Fe | |
| AIG Hospitals,Hyderabad Hyderabad, Telangana | |
| AIG Hospitals,Hyderabad Hyderabad, Telangana | |
| AORN "San Pio"- Benevento Benevento, Bn | |
| AORN "San Pio"- Benevento - UOC Cardiologia Interventistica ed UTIC Benevento, Bn | |
| AORN "Sant'Anna e San Sebastiano" Caserta, Ce | |
| AORN "Sant'Anna e San Sebastiano" Caserta, Ce | |
| AOU Maggiore della Carità di Novara - Dipartimento Toraco-Cardio-Vascolare - SCDU Cardiologia Novara, | |
| AOUI Verona Verona, | |
| AOUI Verona Verona, | |
| ASL Al Di Alessandria - Ospedale Santo Spirito - Casale Monferrato - Cardiologia Casale Monferrato, Al | |
| ASST Fatebenefratelli Ospedale Luigi Sacco Medicina Interna Milan, | |
| ASST Fatebenefratelli Ospedale Luigi Sacco Medicina Interna Milan, | |
| AZ Groeninge - Kortrijk - Cardiology Kortrijk, | |
| AZORG Aalst - Moorselbaan Aalst, | |
| Aakash Healthcare Super Speciality Hospital New Delhi, | |
| Aarhus Universitetshospital, Hjertesygdomme Aarhus N, | |
| Aarhus Universitetshospital, Skejby Hjertesygdomme Aarhus N, | |
| Aberdeen Royal Infirmary Aberdeen, | |
| Adoria Riga, | |
| Advanced Cardiovascular, LLC Alexander City, Alabama | |
| Advanced Heart Care LLC Bridgewater, New Jersey | |
| Advocate Good Samaritan Downers Grove, Illinois | |
| Afyonkarahisar Health Sciences University Afyonkarahisar, | |
| Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Kardiyoloji Afyonkarahisar, | |
| Akdeniz University Medical Faculty Antalya, | |
| Akdeniz University Medical Faculty Antalya, | |
| Akershus universitetssykehus HF Lørenskog, | |
| Al-Zoebi Wermsdorf, | |
| Albert Schweitzer Ziekenhuis locatie Dordwijk Dordrecht, | |
| Alexandra General Hospital, Therapeutic Clinic Athens, | |
| Alexandra General Hospital, Therapeutic Clinic Athens, | |
| Aligarh Muslim University Aligarh, | |
| All India Institute of Medical Sciences (AIIMS) New Delhi, National Capital Territory of Delhi | |
| All India Institute of Medical Sciences (AIIMS) New Delhi, National Capital Territory of Delhi | |
| All India Institute of Medical Sciences (AIIMS), Jodhpur Jodhpur, Rajasthan | |
| Allegheny Health Network Pittsburgh, Pennsylvania | |
| Alta Clinical Research Edmonton, Alberta | |
| Amavita Research Services, LLC North Miami Beach, Florida | |
| American Heart of Poland S.A. Zgierz, | |
| American Heart of Poland S.A. Zgierz, | |
| American Heart of Poland S.A. Zgierz, | |
| American Heart of Poland S.A. Zgierz, | |
| American Heart of Poland S.A. Zgierz, | |
| American Heart of Poland S.A. Zgierz, | |
| American Heart of Poland S.A. Zgierz, | |
| American Heart of Poland S.A. Zgierz, | |
| American Heart of Poland S.A. Zgierz, | |
| Amkardia s.r.o. Brno, | |
| Amrita Institute of Medical Sciences Kochi, Kerala | |
| Ankara Sehir Hastanesi Cardiology Ankara, | |
| Ankara Sehir Hastanesi Cardiology Ankara, | |
| Apex Research Foundation, LLC Jackson, Tennessee | |
| Aphp-Hopital La Pitie Salpetriere-1 Paris, | |
| Aphp-Hopital Lariboisiere-1 Paris, | |
| Arina Trial Research Kft. Orosháza, Bekes County | |
| Arneja Heart & Multispeciality Hospital Nagpur, Maharashtra | |
| Asahikawa-Kosei General Hospital_Cardiology Hokkaido, | |
| Asan Medical Center Seoul, | |
| Ascension Saint Agnes Heart Ca Baltimore, Maryland | |
| Asha Clinical Rsch-Munster, LLC Hammond, Indiana | |
| Associação Lar São Francisco de Assis na Providência de Deus - Bragança Paulista Bragança Paulista, São Paulo | |
| Asst Papa Giovanni XXIII Bergamo, | |
| Audie L. Murphy VA Hospital San Antonio, Texas | |
| Aultman Hospital Canton, Ohio | |
| Aurora St. Luke's Medi Ctr Milwaukee, Wisconsin | |
| Austin Heart Austin, Texas | |
| Azienda Ospedaliera Dei Colli - Monaldi - Centro ricerche cardiologiche Napoli, | |
| Azienda Ospedaliera San Gerardo Monza, | |
| Azienda Ospedaliera Universitaria Senese Siena, Si | |
| Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia Perugia, Pg | |
| Azienda Ospedaliera di Rilievo Nazionale AORN Dei Colli, "V.Monaldi", Napoli, | |
| Azienda Ospedaliero-Universitaria Renato Dulbecco Catanzaro, Cz | |
| Azienda Sanitaria Locale Roma 1 - Ospedale San Filippo Neri - Cardiologia Clinica Roma, Rm | |
| Azienda Sanitaria Ospedaliera Ordine Mauriziano SC Cardiologia Torino, To | |
| Azienda Sanitaria Ospedaliera Ordine Mauriziano SC Cardiologia Torino, To | |
| Azienda Sanitaria Univ Giuliano Isontina Trieste, | |
| Azienda Sanitaria Univ Giuliano Isontina Trieste, | |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Bergamo, Lombardy | |
| B J Goverment Medical College and Sassoon General Hospital Pune, Maharashtra | |
| BENIMED, s.r.o. Piešťany, | |
| Balticmed Świnoujście Sp. z o. o. Świnoujście, | |
| Banner University Medical Ctr Phoenix, Arizona | |
| Banner University Medical Ctr Phoenix, Arizona | |
| Banphaeo General Hospital Samutsakhon, | |
| Baptist Health Hardin Elizabethtown, Kentucky | |
| Baptist Health Louisville Louisville, Kentucky | |
| Baptist Health Research Institute Jacksonville, Florida | |
| Baptist Health South Florida Miami, Florida | |
| Barnabas Health Livingston, New Jersey | |
| Barwon Health (The Geelong Hospital) Geelong, Victoria | |
| Basildon University Hospital Basildon, Essex | |
| Basildon University Hospital Basildon, Essex | |
| Beijing Anzhen Hospital, Capital Medical University Beijing, Beijing Municipality | |
| Bella Praxis S.R.L. Paşcani, | |
| Betegápoló Irgalmasrend, Budai Irgalmasrendi Kórház Budapest, | |
| Biopharma Clinical Research Services, LLC Los Angeles, California | |
| Biopharma Informatic_Houston Houston, Texas | |
| Bispebjerg og Frederiksberg Hospital Frederiksberg, | |
| Borsod-Abaúj-Zemplén Vármegyei Központi Kórház És Egyetemi Oktatókórház Miskolc, | |
| Bridgeport Hospital Bridgeport, Connecticut | |
| Bucheon Sejong Hospital Bucheon-si, Gyeonggi-do | |
| Buddhachinaraj Hospital_Cardiology Phitsanulok, | |
| Békés Vármegyei Központi Kórház Gyula, | |
| Békés Vármegyei Központi Kórház Gyula, | |
| CARDIO D&R, s.r.o. Košice, | |
| CCIH-Consultoria em Controle de Infecção Hospitalar Ltda Belo Horizonte, Minas Gerais | |
| CEDIR - Centro de diagnóstico y rehabilitación Santa Fe Santa Fe, | |
| CEMEDIC CABA, | |
| CEMEDIC CABA, | |
| CHEAR Center LLC The Bronx, New York | |
| CHR de la Citadelle Liège, | |
| CHU de Montréal Montreal, Quebec | |
| CIMS- Care Institute of Medical Sciences Ahmedabad, Gujarat | |
| CINCAME Tijuana, Estado de Baja California | |
| CIP Centro Integrado de Pesquisas do Hospital de Base São José do Rio Preto, São Paulo | |
| CISSSL Hôsp Pierre-Le Gardeur Terrebonne, Quebec | |
| CIUSSS de l'E CHUS_Sherbrooke Sherbrooke, Quebec | |
| CMI Dr. Cristian Podoleanu Târgu Mureş, Targu Mures | |
| CMU - Hematology and Oncology Chiang Mai, | |
| CPS Research Waterloo, Ontario | |
| Cabinet Medical de Cardiologie Dr. Calin Pop Baia Mare, | |
| Cambridge Cardiac Care Centre Cambridge, Ontario | |
| Cambridge Medical Trials Alexandria, Louisiana | |
| Capital Area Research LLC Camp Hill, Pennsylvania | |
| Capital Cardiology Associates_Albany Albany, New York | |
| Capitol Cardiology Assoc_Lanham Lanham, Maryland | |
| Card Specialists of Willowbrook Houston, Texas | |
| Cardiac Clinical Research Unit, University of Cape Town Cape Town, Western Cape | |
| Cardio Partners Clin Res Inst Wellington, Florida | |
| Cardio-Vajira Bangkok, | |
| Cardio-Vajira Bangkok, | |
| CardioVasc HR Inc Saint-Jean-sur-Richelieu, Quebec | |
| Cardiolg Assoc Rsch LLC_Tupelo Tupelo, Mississippi | |
| Cardiolink Clin Trials S.C. Monterrey, Nuevo León | |
| Cardiolink Clin Trials S.C. Monterrey, Nuevo León | |
| Cardiologicum Dresden und Pirna - MVZ "Am Felsenkeller" (Dresden) Dresden, | |
| Cardiology & Medicine Clinic Little Rock, Arkansas | |
| Cardiology Associates of Fairfield County Stamford, Connecticut | |
| Cardiology Research_Bloemfontein Bloemfontein, Free State | |
| Cardiology and Rehabilitation Clinic Klaipėda, | |
| Cardiomed SRL Craiova, | |
| Cardiovascular Rsrch of NW_IN Munster, Indiana | |
| CardiovidCentro Cardiovascular Colombiano ClinicaSantaMaria Medellín, | |
| Care Clinic Sp. z o. o. Katowice, | |
| Care Clinic Sp. z o. o. Katowice, | |
| Carient Heart and Vascular Manassas, Virginia | |
| Carteret Medical Group Morehead City, North Carolina | |
| Centre Hospitalier Intercommunal Toulon La Seine-Sur-Mer - Hopital Sainte Musse Toulon, | |
| Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-1 Grenoble, | |
| Centre Hospitalier Universitaire de Montpellier-Hopital Arnaud de Villeneuve Montpellier, | |
| Centre Hospitalier Universitaire de Poitiers Poitiers, | |
| Centre Hospitalier Universitaire de Poitiers Poitiers, | |
| Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1 Toulouse, | |
| Centre Hospitalier de Pau - Hopital Francois Mitterrand Pau, | |
| Centricity Research Oshawa Oshawa, Ontario | |
| Centro Hospitalar Lisboa Norte Lisbon, | |
| Centro de Atención e Investigación Médica S.A.S. (CAIMED SAS) Chía, Cundinamarca | |
| Centro de Diag. e Pesquisa da Osteoporose do Espírito Santo Vitória, Espírito Santo | |
| Centro de Estudios Clinicos de Querétaro S.C. Querétaro, | |
| Centro de Imagen y Tecnologia en Intervención Cardiovascular México, La Magdalena Contreras | |
| Centro de Investigaciones Clinica Baigorria Santa Fé, Santa Fe Province | |
| Centro de Investigaciones Clinica Baigorria Santa Fé, Santa Fe Province | |
| Centro de Investigaciones Clinicas del Litoral Santa Fe, | |
| Centro de Investigaciones Medicas Mar del Plata Mar del Plata, | |
| Centro de Investigaciones Médicas Clínica de Fracturas y Or Mar del Plata, | |
| Centro de Investigaciones Médicas Clínica de Fracturas y Or Mar del Plata, | |
| Centro de Investigación Biomédica y Farmacéutica S.C. Mexico City, | |
| Centro de Investigación y Control Metabólico S. C. San Nicolás de los Garza, Nuevo León | |
| Centro de atención e investigación cardiovascular del Potosí San Luis Potosí City, | |
| Centro para el Desarrollo de la Medicina y la Asistencia Culiacán, Sinaloa | |
| Centrul Medical Emerald Bucharest, | |
| Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed Brasov, | |
| Cerrahpaşa Kardiyoloji Enstitüsü Istanbul, | |
| Chang Gung Medical Foundation - Linkou Branch Taoyuan District, | |
| Chang Gung Memorial Hospital - Kaohsiung Branch Kaohsiung City, | |
| Changi General Hospital Singapore, | |
| Changsha Central Hospital Changsha, Hunan | |
| Changzhou No.2 People's Hospital, Yanghu Branch Changzhou, Jiangsu | |
| Charite Universitätsmedizin Berlin KöR Berlin, | |
| Charité - Campus Virchow-Klinikum - Kardiologie, Angiologie und Intensivmedizin (CRU) Berlin, | |
| Chiang Rai Prachanukroh Hospital Chiang Rai, | |
| Chicago Medical Research LLC Hazel Crest, Illinois | |
| China-Japan Friendship Hospital Beijing, | |
| China-Japan Friendship Hospital Beijing, | |
| China-Japan Union Hospital of Jilin University-Cardiology Changchun, Jilin | |
| Chinese Academy of Medical Sciences Fuwai Hospital Beijing, Beijing Municipality | |
| Chongqing University Three Gorges Hospital Chongqing, | |
| Chongqing University Three Gorges Hospital Chongqing, | |
| Chonnam National University Hospital Gwangju, | |
| Chru de Nancy - Hopital Brabois Vandœuvre-lès-Nancy, | |
| Chulabhorn Hospital Lak Si, | |
| Chulabhorn hospital_Cardiovascular Bangkok, | |
| Chungbuk National University Hospital Cheongju-si, North Chungcheong | |
| Chungnam National University Hospital Daejeon, | |
| Chutoen General Medical Center_Cardiology Shizuoka, | |
| Clinica Imbanaco SAS Santiago de Cali, Valle del Cauca Department | |
| Clinica de la Costa Barranquilla, Atlántico | |
| Clinical Advancement Ctr, PLLC San Antonio, Texas | |
| Clinical Best Solutions Sp. z o.o., Sp. k Lublin, | |
| Clinical Centre of Serbia, Emergency Centre, Department of Cardiology Belgrade, | |
| Clinical Centre of Serbia, Emergency Centre, Department of Cardiology Belgrade, | |
| Clinical Hospital Center Bezanijska Kosa Belgrade, | |
| Clinical Hospital Centre Osijek Osijek, | |
| Clinical Hospital Centre Zemun Belgrade, | |
| Clinical Projects Research Worcester, Western Cape | |
| Clinical Projects Research Worcester, Western Cape | |
| Clinical Research Institute of South Africa KwaDukuza, KwaZulu-Natal | |
| Clinical Research Institute of South Africa KwaDukuza, KwaZulu-Natal | |
| Clinical Research Solutions Inc. Waterloo, Ontario | |
| Clinical Trials Service s.r.o. Uherské Hradiště, | |
| Clinical Trials Service s.r.o. Uherské Hradiště, | |
| Clinical centre of Serbia, Clinic for cardiology Belgrade, | |
| Clinitrials Perth, Western Australia | |
| Clínica Nuevas Tecnologías en Diabetes y Endocrinología Seville, | |
| Colosseumklinikken Medisinske Senter AS Oslo, | |
| Complejo Hospitalario Universitario A Coruna A Coruña, | |
| Concord Repatriation General Hospital - Cardiology Concord, New South Wales | |
| Concord Repatriation General Hospital - Cardiology Department Concord, New South Wales | |
| Corazón IPS S.A.S Barranquilla, | |
| Cork University Hospital Cork, | |
| Coromed SMO Kft. Pécs, | |
| Craigavon Area Hospital_Cardiovascular Research Unit Craigavon, | |
| Ctr de méd métab de Lanaudière Terrebonne, Quebec | |
| Ctr for Cardiovascular Innovation Vancouver, British Columbia | |
| DCC 1 - Lom EOOD Lom, | |
| DCC Aleksandrovska EOOD Sofia, | |
| DCC Ascendent OOD Sofia, | |
| DIM Clinica Privada Buenos Aires, | |
| DRC Kft. Balatonfüred, | |
| Dallas Heart and Vascular Duncanville, Texas | |
| David Turbay, MD, PLLC El Paso, Texas | |
| Davius Clinicmed Srl Bucharest, | |
| Dawson Clinical Research Guelph, Ontario | |
| Dayanand Medical College & Hospital Ludhiana, Punjab | |
| Deep Hospital Ludhiana, Punjab | |
| Detroit Med Center-Wayne State Detroit, Michigan | |
| Deventer Ziekenhuis Deventer, | |
| Diabetes Heart Research Centre Toronto, Ontario | |
| Diagnostic Consulting Center 1- Lom EOOD Lom, | |
| Diex Recherche Trois-Rivieres Trois-Rivières, Quebec | |
| Diseño y Planeacion en Investigacion Medica S.C. Guadalajara, Jalisco | |
| Dokuz Eylul University School of Medicine, Cardiology Izmir, | |
| Donna Medplus S.R.L. Bucharest, | |
| Donna Medplus S.R.L. Bucharest, | |
| Dr B L Kapur Memorial Hospital New Delhi, | |
| Dr Corbett Cape Town, Western Cape | |
| Dr Garda Cardiology Practice Johannesburg, Gauteng | |
| Dr Hendrik Snyman's Practice Mossel Bay, Western Cape | |
| Dr Mpe's Practice Pretoria, Gauteng | |
| Dr. Abdulah Nakas General Hospital Sarajevo, | |
| Dr. Abdulah Nakas General Hospital Sarajevo, | |
| Dr. Lakatos Ferenc Kardiológus ,Belgyógyász Magán szakrendelés Békéscsaba, Bekes County | |
| Dr. Siyami Ersek Gogus Kalp ve Damar Cerrahisi EAH Istanbul, | |
| Duke University Durham, North Carolina | |
| Duke University/Southeastern Lumberton, North Carolina | |
| Duke University/Southeastern Lumberton, North Carolina | |
| E Coast Inst for Rsrch LLC_Jacksonville Jacksonville, Florida | |
| EMED Centrum Usług Medycznych Ewa Smialek Rzeszów, | |
| EPIC Hospital Ahmedabad, Gujarat | |
| EURÉKA-CENTER Orvosi és Szolgáltató Betéti Társaság Baja, | |
| East Rand Physicians Benoni, Gauteng | |
| East Tallinn Central Hospital Tallinn, | |
| Eastern Shore Rsrch Inst, LLC Fairhope, Alabama | |
| Echipa Medical.33 S.R.L Timișoara, | |
| Ecocard Srl Bucharest, | |
| Ecocard Srl Bucharest, | |
| Ege University School of Medicine, Cardiology Department Izmir, | |
| Elite Research Center Flint, Michigan | |
| Emergency Institute For Cardiovascular Diseases And Transplant Târgu Mureş, | |
| Emergency Internal Medicine Clinic Belgrade, | |
| Emergency Internal Medicine Clinic Belgrade, | |
| Emory University School of Medicine_Atlanta Atlanta, Georgia | |
| Endeavor Health Clinical Operations-NCH Arlington Heights, Illinois | |
| Epworth Healthcare Melbourne, Victoria | |
| Erasmus MC Rotterdam, | |
| Erciyes University Cardiology Kayseri, | |
| Eskisehir Osmangazi University-Cardio Eskişehir, | |
| Eukarya Pharmasite S.C. Monterrey, Nuevo León | |
| Eurolatino Medical Research Center Uberlândia, Minas Gerais | |
| Excellentis Clinical Trial Consultants George, Eastern Cape | |
| FN Hradec Kralove Hradec Králové, | |
| FN Hradec Kralove Hradec Králové, | |
| Facharztzentrum Dresden Betriebsgesellschaft mbH Dresden, | |
| Fairview Health Services Maplewood, Minnesota | |
| Fakultna Nemocnica Trnava Trnava, | |
| Fakultni nemocnice Plzen - Lochotin Plzen - Lochotín, | |
| Fakultní poliklinika VFN ambulance Srdecniho selhani Prague, | |
| Fakultní poliklinika VFN ambulance Srdecniho selhani Prague, | |
| Fließer-Görzer [Ordination] Saint Stefan, | |
| Fließer-Görzer [Ordination] Saint Stefan, | |
| Flinders Medical Centre Bedford Park, | |
| Fondazione CNR-Regione Toscana Gabriele Monasterio Pisa, Pi | |
| Fondazione IRCCS Policlinico San Matteo Pavia, | |
| Fondazione IRCCS Policlinico San Matteo Pavia, | |
| Fondazione Salvatore Maugeri I.R.C.C.S. - Bari Bari, | |
| Fondazione Toscana Gabriele Monasterio - Dipartimento Cardiotoracico - UOC Cardiologia e Medicina Cardiovascolare Pisa, Pi | |
| Fortis Escorts Heart Institute, New Delhi New Delhi, National Capital Territory of Delhi | |
| Fortis Hospital, Mohali Mohali, Punjab | |
| Franciscan Network-IN Heart PHY Indianapolis, Indiana | |
| Franciscan Network-IN Heart PHY Indianapolis, Indiana | |
| Frankston Hospital Frankston, Victoria | |
| Fukuoka University Hospital_Cardiology Fukuoka-shi, Fukuoka, | |
| Fundacion Favaloro CABA, Buenos Aires, Argentina | |
| Fundacion Favaloro CABA, Buenos Aires, Argentina | |
| Fundacion Favaloro CABA, Buenos Aires, Argentina | |
| Fundacion Respirar Buenos Aires, B | |
| Fundacion Santa Fe de Bogota Bogotá, | |
| Fundacion del Caribe para la Investigacion Biomedica-BIOS Barranquilla, | |
| Fundacion del Caribe para la Investigacion Biomedica-BIOS Barranquilla, | |
| Fundación Hospital Universidad del Norte Soledad, Barranquilla | |
| Fundación Hospital Universidad del Norte Soledad, Barranquilla | |
| Fundación para la Investigación del Hospital Clínico de Valencia (INCLIVA) Valencia, | |
| G B Pant Institute of Postgraduate Medical Education and Research New Delhi, National Capital Territory of Delhi | |
| G.A. Research Associates Ltd. Moncton, New Brunswick | |
| GA Arrhythmia Cons & Rsch Inst Macon, Georgia | |
| GK Neiroklinika Riga, | |
| GNRC Hospital Guwahati, Assam | |
| Gachon University Gil Medical Center Incheon, | |
| Geisinger Medical Center Danville, Pennsylvania | |
| General Hospital "Euromedik 2" Belgrade, | |
| General Hospital Of Mytilene Vostanio Mytilene, | |
| General Hospital of Athens "Elpis" Ampelokipoi/Athens, | |
| General Hospital of Chalkida Chalcis, | |
| General Hospital of Chios "Skilitsio" Chios, | |
| General Hospital of Kalamata Kalamata, | |
| General Hospital of Ningxia Medical University Ningxia, Yinchuan | |
| General Hospital of Thessaloniki 'G. Gennimatas Thessaloniki, | |
| General Oncological Hospital of Kifissia Agioi Anargyroi Kifissia, | |
| General University Hospital of Patras Rio, Patras | |
| General University Hospital of Patras Rio, Patras | |
| General hospital Celje - cardiology Celje, | |
| Genl Hospital of Athens Ippokrateio,A' Cardiology Univ dpt Athens, | |
| Gesundheitscentrum Mainz (Regner / Schmitt) Mainz, | |
| Glasgow Clinical Research Facility Glasgow, | |
| Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach Katowice, Silesian Voivodeship | |
| Gosford Hospital Gosford, | |
| Gottsegen György Országos Kardiológiai Intézet Budapest, | |
| Government Medical College and Super Speciality Hospital, Nagpur Nagpur, Maharashtra | |
| Government Medical College, Kozhikode Kozhikode, Kerala | |
| Guardian Research Org LLC Winter Park, Florida | |
| Guru Nanak CARE Hospitals Hyderabad, Telangana | |
| Guru Nanak CARE Hospitals Hyderabad, Telangana | |
| Gyncentrum Sp. z o. o. Katowice, | |
| Gyncentrum Sp. z o. o. Katowice, | |
| HUS, Sydän- ja keuhkokeskus, kardiologian tutkimusyksikkö HUS, | |
| Hacettepe University Medical Faculty_Ankara Ankara, | |
| Hadassah Ein Karam MC - Cardio Department Jerusalem, | |
| Haga Ziekenhuis The Hague, | |
| Hainan General Hospital Haikou, | |
| Hainan General Hospital Haikou, | |
| Hallym University Sacred Heart Hospital Anyang, | |
| Hamanomachi Hospital_Cardiovascular medicine Fukuoka, | |
| Hamilton Hlth Sc. - General Site Hamilton, Ontario | |
| Harlem Cardiology_Madison ave New York, New York | |
| Haukeland Universitetssykehus Bergen, | |
| Hawthorne Health Diamondhead, Mississippi | |
| Hawthorne Health NC Concord, North Carolina | |
| Health Sciences North Rsrch Inst Greater Sudbury, Ontario | |
| Health Step Finland Oy Kuopio, | |
| Healthy Heart Cardiology Grand Rapids, Michigan | |
| Heart Center Rsrch_Hunstville Huntsville, Alabama | |
| Heart Clinic of Hammond Hammond, Louisiana | |
| Heart Grp_ Lancaster Gen Hlth Lancaster, Pennsylvania | |
| Heart House_Elmer Elmer, New Jersey | |
| Heart MD_Allen TX Allen, Texas | |
| Heart of Australia Chelmer, Queensland | |
| HeartWest Cardiology - Hoppers Crossing Hoppers Crossing, Victoria | |
| Hebei General Hospital Shijiazhuang, Hebei | |
| Henry Ford Hlth System_Detroit Detroit, Michigan | |
| Herlev og Gentofte Hospital Hellerup, Capital Region | |
| Herz-Kreislauf-Zentrum Klinikum Hersfeld-Rotenburg GmbH Rotenburg A.d. Fulda, | |
| Hightech Medical Services S.R.L. Bucharest, | |
| Hillel Yafe MC - Cardiology Department Hadera, | |
| Hippokration Hospital Athens, | |
| Hospital Angeles de Xalapa Xalapa, Veracruz | |
| Hospital Angeles de Xalapa Xalapa, Veracruz | |
| Hospital Canselor Tuanku Muhriz UKM Cheras, | |
| Hospital Cardiologica Aguascalientes Aguascalientes, Aguascalientes | |
| Hospital Cardiologica Aguascalientes Aguascalientes, Aguascalientes | |
| Hospital Clinic i Provincial Barcelona, | |
| Hospital Clinico San Carlos Madrid, | |
| Hospital Cuf Descobertas S.A. Lisbon, | |
| Hospital Da Luz S.A. Lisbon, | |
| Hospital Del Mar Barcelona, | |
| Hospital General de Medellin Medellín, Antioquia | |
| Hospital General de Medellin Medellín, Antioquia | |
| Hospital General de Valencia Valencia, | |
| Hospital Germans Trias I Pujol Badalona, | |
| Hospital Italiano Buenos Aires, | |
| Hospital Kuala Lumpur Kuala Lumpur, | |
| Hospital Mãe de Deus - Porto Alegre Porto Alegre/RS, | |
| Hospital Ramon Y Cajal Madrid, | |
| Hospital Serdang Kajang, Selangor | |
| Hospital Serdang Kajang, Selangor | |
| Hospital Sultanah Aminah Johor Bahru, Johor | |
| Hospital Sultanah Aminah Johor Bahru, Johor | |
| Hospital Sultanah Bahiyah Alor Setar, Kedah, | |
| Hospital São Lucas Copacabana Rio de Janeiro, | |
| Hospital Tengku Ampuan Afzan Kuantan, Pahang | |
| Hospital Univ. de Gran Canaria Doctor Negrín Las Palmas de Gran Canaria, | |
| Hospital Universitario La Luz Madrid, | |
| Hospital Universitario La Paz Madrid, | |
| Hospital Universitario Puerta de Hierro Majadahonda Majadahonda, | |
| Hospital Universitario Puerta de Hierro Majadahonda Majadahonda, | |
| Hospital Universitario de Gran Canaria Doctor Negrín Las Palmas de Gran Canaria, | |
| Hospital Universiti Kebangsaan Malaysia Kuala Lumpur, | |
| Hospital Universiti Sains Malaysia Kota Bharu, Kelantan | |
| Hospital Vithas Sevilla Seville, | |
| Hospital da Luz Lisbon, | |
| Hospital da Luz Setúbal Setúbal, | |
| Hospital de Bellvitge L'Hospitalet de Llobregat, | |
| Hospital de Cascais Alcabideche, | |
| Hospital de Clínicas da Universidade Federal de Goiânia Goiânia/GO, | |
| Hospital de Clínicas de Porto Alegre Porto AlegreRS, | |
| Hospital of Lithuanian University of Health Sciences Kauno Klinikos Kaunas, | |
| Houston Methodist Hospital Houston, Texas | |
| Houston Methodist Hospital Houston, Texas | |
| Huai'an First People's Hospital, Nanjing Medical University Huai'an, Jiangsu | |
| Huashan Hospital Fudan University Shanghai, | |
| Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology Himeji-shi, Hyogo, | |
| ICM - Instituto do Coração de Marília Marília, | |
| IPGME&R and SSKM Hospital Kolkata, West Bengal | |
| IPS Centro Cientifico Asistencial Jose Luis Accini SAS Barranquilla, Atlántico | |
| IPS médicos Internistas de Caldas S.A.S. Manizales, Caldas Department | |
| IRCCS Ospedale Policlinico San Martino Genova, | |
| Iatriko Athinon (Athens Medical Canter) Pylea, Thessaloniki, | |
| Iatriko Athinon (Athens Medical Canter) Pylea, Thessaloniki, | |
| Iatros International Bloemfontein, | |
| Imed 19- privat Vienna, | |
| Imed 19- privat Vienna, | |
| Ind. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman Gdynia, Pomeranian Voivodeship | |
| Inha University Hospital Incheon, | |
| Inspira Health Mullica Hill, New Jersey | |
| Institut de Cardiologie de Montreal Montreal, Quebec | |
| Institute for Cardiovascular Diseases ''Dedinje'' Belgrade, | |
| Institute for Cardiovascular Diseases of Vojvodina - Sremska Kamenica Kamenitz, | |
| Instituto D'Or de Pesquisa e Ensino Rio de Janeiro, | |
| Instituto Nacional de Cardiologia Ignacio Chavez Mexico City, | |
| Instituto de Cardiología de Corrientes Corrientes, | |
| Instituto de Investigaciones Clinicas San Nicolas San Nicolás, | |
| Instituto de Investigaciones Clínicas Mar del Plata, | |
| Instituto de Moléstias Cardiovasculares de Tatuí Ltda Tatuí, São Paulo | |
| Instituto de Pesquisa Clinica de Campinas Campinas, São Paulo | |
| Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu Bucharest, | |
| Institutul de Boli Cardiovasculare "Prof. Dr. George I.M. Georgescu" Iași, | |
| Institutul de Boli Cardiovasculare Timisoara Timișoara, | |
| Instytut Centrum Zdrowia Matki Polki Lodz, | |
| Integral Pesquisa e Ensino Votuporanga, | |
| Integrative Research Assoc Inc Fort Lauderdale, Florida | |
| Intercard Spolka z ograniczona odpowiedzialnoscia Pińczów, | |
| Interna SK s.r.o. Svidník, Presov | |
| Internacionalni medicinski centar PRIORA Čepin, | |
| Internal Medicine Clin Trials Monterrey, Nuevo León | |
| Intradia s.r.o. Nitra, | |
| InvivoCure Van Nuys, California | |
| InvivoCure -2 Denver, Colorado | |
| InvivoCure -2 Denver, Colorado | |
| Ishikawa Prefectural Central Hospital_Cardiology Ishikawa, | |
| Iwate Prefectural Central Hospital Morioka-shi, Iwate, | |
| Iwate Prefectural Central Hospital_Cardiology Morioka-shi, Iwate, | |
| JA Shizuoka Kohseiren Enshu Hospital_ cardiology Hamamatsu-shi, Shizuoka, | |
| JCHO Kyushu Hospital_Cardiology Kitakyushu-shi, Fukuoka, | |
| JCHO Tokuyama Community Health Center_Department of Cardiology Yamaguchi, | |
| JIPMER Puducherry, | |
| JSC "Saules seimos medicinos centras" Kaunas, | |
| JSC Inlita Santaros Vilnius, | |
| Jacksonville Ctr for Clin Res Jacksonville, Florida | |
| Jahn Ferenc Del-Pesti Korhaz es Rendelointezet Budapest, | |
| James River Cardiology Chesterfield, Virginia | |
| Jantar Sp. z o.o. Ostrów Wielkopolski, | |
| Japan Community Health care Organization Kyushu Hospital_Cardiology Kitakyushu-shi, Fukuoka, | |
| Jehangir Clinical Development Centre Pune, Maharashtra | |
| Jilin Province People's Hospital-Cardiology Changchun, Jilin | |
| Jmf Clínica Do Coração Ltda Aracaju, | |
| Johese Clinical Research Centurion, Gauteng | |
| John Radcliffe Hospital Oxford, | |
| John Radcliffe Hospital Oxford, | |
| Johns Hopkins University_Baltimore Baltimore, Maryland | |
| Josha Research Bloemfontein, Free State | |
| Juntendo University Hospital_Cardiology Tokyo, | |
| Justus-Liebig-Universität Gießen - Kardiologie Giessen, | |
| K&R Research Llc Marion, Ohio | |
| KARDIO-SANUS, spol. s r.o. Bratislava, | |
| KARDIOLOGIE - LIBEREC s.r.o. Liberec, | |
| KARDIOLOGIE - LIBEREC s.r.o. Liberec, | |
| KB Dubrava, Zavod za bolesti srca i krvnih zila Zagreb, City of Zagreb | |
| KBC Rijeka, Zavod za kardiomiopatije Rijeka, | |
| KBC Split Split, | |
| KEM Hospital Pune, Maharashtra | |
| KKR Tohoku Kosai Hospital_Cardiology Miyagi, | |
| KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre Karnataka, | |
| Kagawa Prefectural Central Hospital, Cardiovascular Medicine Takamatsu-shi, Kagawa, | |
| Kagoshima City Hospital_Cardiovascular Medicine Kagoshima, | |
| Kanagawa Prefectural Hospital Organization Kanagawa Cardiovascular and Respiratory Center_Cardiology Kanagawa, | |
| Kanagawa Prefectural Hospital Organization Kanagawa Cardiovascular and Respiratory Center_Cardiology Kanagawa, | |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, | |
| Kaplan MC - Heart Failure Unit Rehovot, | |
| Kardio Brynów Sp. z o. o. Katowice, | |
| Kardio Life Włocławek, Kuyavian-Pomeranian Voivodeship | |
| Kardiologická a interní ambulance Prague, | |
| Kardiologie Hassloch Haßloch, | |
| Kardiologie MUDr. Libor Nechvátal s.r.o. Brno, | |
| Kardiologie Trutnov Ferkl Trutnov, | |
| Kardiologie Vinohrady s.r.o. Prague, | |
| Kardiologisch-Angiologische Praxis Herzzentrum Bremen Bremen, | |
| Kardiologisch-Angiologische Praxis Herzzentrum Bremen Bremen, | |
| Kardiologische Gemeinschaftspraxis Papenburg Papenburg, | |
| Kardiologisk Odense & Svendborg Svendborg, | |
| Kardiopraxis Schirmer Kaiserslautern, | |
| Kath. Klinikum Bochum gGmbH - St. Josef-Hospital Kardiologie Bochum, | |
| Kath. St. Paulus GmbH - St Johannes Hospital Dortmund - Kardiologie Dortmund, | |
| Kaunas Hospital of the Lithuanian University of Health Sciences Kaunas, | |
| Kawartha Cardiology Clinical Trials Peterborough, Ontario | |
| Keimyung University Dongsan Hospital Daegu, | |
| Keio University Hospital_Cardiology Tokyo, | |
| Khoo Teck Puat Hospital Singapore, | |
| King Chulalongkorn Memorial Hospital Bangkok, | |
| King Chulalongkorn Memorial Hospital Bangkok, | |
| King George's Medical University (KGMU) Lucknow, Uttar Pradesh | |
| King George's Medical University (KGMU) Lucknow, Uttar Pradesh | |
| Kishiwada Tokushukai Hospital_Cardiology Kishiwada-shi, Osaka, | |
| Klaipeda University Hospital Klaipėda, | |
| Klaipeda University Hospital Klaipėda, | |
| Klinik Favoriten Vienna, | |
| Klinik Favoriten Vienna, | |
| Klinik Ottakring Vienna, | |
| Klinikiniai sprendimai, Kaunas Kaunas, | |
| Kocaeli Universitesi Tip Fakultesi Hastanesi Kocaeli, | |
| Konstantopouleio G.H. of Athens, "Agia Olga" Athens, | |
| Korczowski Bartosz Gabinet Lekarski Rzeszów, | |
| Korea University Anam Hospital Seoul, | |
| Korea University Guro Hospital Seoul, | |
| Krankenhaus St. Josef Braunau Braunau am Inn, | |
| Krankenhaus St. Josef Braunau Braunau am Inn, | |
| Kuang Tien General Hospital Taichung, | |
| KwaPhila Health Solutions Durban, KwwaZulu Natal | |
| Kyoto University Hospital Kyoto, | |
| Kyushu University Hospital_Cardiovascular Medicine Fukuoka, | |
| Kyushu University Hospital_Cardiovascular Medicine Fukuoka, | |
| LMU Klinikum München Klinik und Poliklinik 1 München, | |
| Lakshmi Hospital Palakkad, Kerala | |
| Lalitha Super Specialities Hospital Guntur, Andhra Pradesh | |
| Lalitha Super Specialities Hospital Guntur, Andhra Pradesh | |
| Laurelton Heart Specialist PC Rosedale, New York | |
| Lausmed Kft. Baja, Bács-Kiskun county | |
| Lenasia Clinical Trial Centre Lenasia, Gauteng | |
| Lishui People's Hospital Lishui, Zhejiang | |
| Lishui People's Hospital-Cardiology Lishui, Zhejiang | |
| Lisie Hospital Kochi, Kerala | |
| Logan Health Research Kalispell, Montana | |
| Lotus Med SRL Bucharest, | |
| Louisiana Heart Center Bogalusa, Louisiana | |
| Lundquist Inst-Biomed Innovtn Torrance, California | |
| Léda Platán Magánklinika Zalaegerszeg, Zala County | |
| MD Medical Research Oxon Hill, Maryland | |
| MDHAT "Dr. Stephen Cherkezov" AD Veliko Tarnovo, | |
| MED-CENTRUM, s.r.o. Martin, | |
| MEDIVASA, s.r.o., Kardiologicka ambulancia 1, 2 Žilina, | |
| MHAT "Knyaginya Klementina" -Sofia EAD Sofia, | |
| MHAT Heart and Brain Pleven, | |
| MHAT Heart and Brain EAD Burgas, | |
| MHAT Sveta Sofia EOOD Sofia, | |
| MS Ramaiah Bengaluru, | |
| MS Ramaiah Bengaluru, | |
| MVZ CCB Frankfurt Und Main-Taunus GbR Frankfurt, | |
| Maastricht Universitair Medisch Centrum Maastricht, | |
| Maharaj Nakorn Chiang Mai Hospital Chiang Mai, | |
| Maharat Nakhon Ratchasima Hospital Nakhon Ratchasima, | |
| Manchester Royal Infirmary_Manchester_0 Manchester, | |
| Manipal Hospital, Old Airport Road, Bengaluru Bangalore, Karnataka | |
| Manshadi Heart Institute Stockton, California | |
| Marian David, MD, PC Kew Gardens, New York | |
| Mat Cord Biomedica S.R.L. Buzău, | |
| Mater Miscericordiae Hospital Dublin, | |
| Mater Private Network - Dublin Dublin, | |
| Mater Private Network Cork Mahon, Cork, | |
| Mautalen Salud e investigación CABA, Buenos Aires | |
| Medanta - The Medicity Multi-Speciality Hospital, Gurugram Gurugram, Haryana | |
| MediNess Sp. z o.o. Krakow, Lesser Poland Voivodeship | |
| MediNess Sp. z o.o. Krakow, Lesser Poland Voivodeship | |
| Medical Centre - Avitsena EOOD Kardzhali, | |
| Medical Centre Cardiomed 2020 EOOD Sliven, | |
| Medical Centre Hera - Kyustendil EOOD Kyustendil, | |
| Medical Centre Intermedica OOD Sofia, | |
| Medical Centre Nevromedics EOOD Veliko Tarnovo, | |
| Medical Network Sp. z o. o. Warsaw, | |
| Medical Network Sp. z o. o. Warsaw, | |
| Medical center ISUL - Tsaritsa Yoanna EOOD Sofia, | |
| Medical center Leskovac Leskovac, | |
| Medical center Uzice Užice, | |
| Medical centre "Zdrave 1" OOD Kozloduy, | |
| Medical centre Health Care OOD Sandanski, | |
| Medication Mgmnt, LLC_Grnsboro Greensboro, North Carolina | |
| Medisch Spectrum Twente Enschede, | |
| Medizinische Universität Graz Graz, | |
| Medizinische Universität Graz Graz, | |
| Medizinische Universität Wien Vienna, | |
| Medizinische Universität Wien Vienna, | |
| Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training Research Hospital_Istanbul Istanbul, | |
| Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training Research Hospital_Istanbul Istanbul, | |
| Memorial Region Hosp_Hollywood Hollywood, Florida | |
| Mersin University Cardiology Mersin, | |
| Methodist Medical Center of Illinois Peoria, Illinois | |
| Mianyang Central Hospital-Cardiology Mianyang, Sichuan | |
| Midwest Cardiovascu Rsrch Foundation Elkhart, Indiana | |
| Midwest Cardiovascular Institute Naperville, Illinois | |
| Midwest Heart & Vasc Spec Overland Park, Kansas | |
| Midwest Heart & Vasc Spec Overland Park, Kansas | |
| Mie Prefectural General Medical Center_Cardiology Mie, | |
| Minneapolis VA Health Care Sys Minneapolis, Minnesota | |
| Mitoyo General Hospital_Cardiovascular medicine Kagawa, | |
| Monument Health Clinical Rsrch Rapid City, South Dakota | |
| Morehouse School of Medicine Atlanta, Georgia | |
| Mount Sinai Hosp at NYC New York, New York | |
| Mount Sinai Hosp at NYC New York, New York | |
| NCH Research Institute Naples, Florida | |
| NJ Heart Linden, New Jersey | |
| NJ Heart Linden, New Jersey | |
| NSC Research, Inc Johns Creek, Georgia | |
| NUPEC Cardio Belo Horizonte, | |
| NY Presbyt Hosp-W Cornell Med New York, New York | |
| NZOZ Centrum Medyczne SERAFIN-MED Halina Serafin Żarów, | |
| Nagasaki Harbor Medical Center_Cardiovascular medicine Nagasaki, | |
| Narayana Institute of Cardiac Sciences Bengaluru, Karnataka | |
| Narodny ustav srdcovych a cievnych chorob, a.s. Bratislava, | |
| Narodny ustav srdcovych a cievnych chorob, a.s. Bratislava, | |
| National Cerebral and Cardiovascular Center Hospital_Department of Heart Failure Osaka, | |
| National Heart Centre Singapore Singapore, | |
| National Heart Institute Cal Beverly Hills, California | |
| National Hospital Organization Iwakuni Clinical Center_Cardiovascular Medicine Yamaguchi, | |
| National Hospital Organization Mito Medical Center_Cardiovascular medicine Ibaraki, | |
| National Hospital Organization Osaka National Hospital_Cardiovascular Division Osaka, | |
| National Hospital Organization Sendai Medical Center_Cardiovascular medicine Miyagi, | |
| National Multiprofile Transport Hospital "Tsar Boris III" Sofia, | |
| National University Hospital Singapore Singapore, | |
| Nature Coast Clin Rsrch_Crystal River Crystal River, Florida | |
| Nemocnica S Poliklinikou Brezno N.O. Brezno, Banská Bystrica Region | |
| Nemocnice Slany Kardiologie Slaný, | |
| Nemocnice Slany Kardiologie Slaný, | |
| Nemocnicna a.s. Malacky, | |
| Neurocord Medical SRL Craiova, | |
| Neurocord Medical SRL Craiova, | |
| New Generation of Medical Research Hialeah, Florida | |
| New Generation of Medical Research Hialeah, Florida | |
| Nightingale Research Adelaide, South Australia | |
| Nirmal Hospital Pvt. Ltd. Surat, Gujarat | |
| North America Research Institute San Dimas, California | |
| North Estonia Medical Centre Foundation Tallinn, | |
| North Shore Heart Centre North Vancouver, British Columbia | |
| North Shore Heart Centre North Vancouver, British Columbia | |
| North Tyneside General Hospital North Shields, | |
| North York Diagn & Cardiac Ctr North York, Ontario | |
| Northern Jiangsu People's Hospital Yangzhou, | |
| Northern Jiangsu People's Hospital Yangzhou, | |
| Nova Scotia Health Halifax, Nova Scotia | |
| OLVG Oost Amsterdam, | |
| OSF HealthCare_Cardiovasc Inst Rockford, Illinois | |
| Ocala Cardiovascular Research Ocala, Florida | |
| Ogaki Municipal Hospital_Cardiology Gifu, | |
| Okayama City General Medical Center Okayama City Hospital_Cardiovascular Medicine Okayama, | |
| Okayama Medical Center_Cardiology Okayama, | |
| Okayama University Hospital_Cardiovascular Medicine Okayama-shi, Okayama, | |
| Okayama University Hospital_Cardiovascular Medicine Okayama-shi, Okayama, | |
| Opca bolnica Karlovac Karlovac, | |
| Opca bolnica Karlovac Karlovac, | |
| Ormond Beach Clinical Research Ormond Beach, Florida | |
| Osaka University Hospital_Cardiovascular medicine Osaka, | |
| Oslo universitetssykehus HF - Ullevål Oslo, | |
| Osmania General Hospital Hyderabad, Telangana | |
| Osmania General Hospital Hyderabad, Telangana | |
| Ospedale Ca' Foncello Treviso, Veneto | |
| Ospedale Misericordia Grosseto Grosseto, | |
| Ospedale Santo Spirito Casale Monferrato, Al | |
| Ospedali riuniti di Foggia Foggia, | |
| P. Stradins Clinical University Hospital Riga, | |
| PHI City General Hospital 8th September Skopje, | |
| PHI University Clinic for Cardiology Skopje, | |
| PHI University Clinic for Cardiology Skopje, | |
| PROCAPE Recife/PE, | |
| PTE ÁOK I. sz. Belgyógyászati Klinika Pécs, Baranya | |
| PTE ÁOK I. sz. Belgyógyászati Klinika Pécs, Baranya | |
| PUCCAMP - Hospital e Maternidade Celso Pierro Campinas, São Paulo | |
| PUCPR - Pontificia Universidade Catolica do Parana Curitiba, Paraná | |
| Palm Research Center Inc. Las Vegas, Nevada | |
| Panek Med Centrum Leczenia Chorob Naczyn Bialystok, Podlaskie Voivodeship | |
| Partnrs Adv Cardio Eval (PACE) Newmarket, Ontario | |
| Peking University Third Hospital-Cardiology Beijing, Beijing Municipality | |
| Penn State Health-Berks Cardiology Wyomissing, Pennsylvania | |
| Penn State Hershey Medical Center Hershey, Pennsylvania | |
| Penn State Hlth Holy Spirit Med Ctr Camp Hill, Pennsylvania | |
| Pentucket Medical Associates Haverhill, Massachusetts | |
| Periphery University Hospital of Heraklion Heraklion, Crete | |
| PharmaTex Research, LLC Amarillo, Texas | |
| Pioneer Clinical Studies-Coral Gables Coral Gables, Florida | |
| Policska nemocnice Polička, | |
| Poliklinika Aritmija Zagreb, City of Zagreb | |
| Poliklinika Magnolija d.o.o. Zagreb, | |
| Poliklinika Medikol_Cakovec_Cardiology Čakovec, | |
| Poliklinika Solmed Zagreb, City of Zagreb | |
| Polimedica Centrum Badań, Profilaktyki i Leczenia Sp. z o. o. Warsaw, | |
| Polimedica Centrum Badań, Profilaktyki i Leczenia Sp. z o. o. Warsaw, | |
| Poličská nemocnice s.r.o. Polička, | |
| Poradnia Aka-Med Centrum Sp. z o.o. Ruda Śląska, Silesian Voivodeship | |
| Post Graduate Institute of Medical Education & Research_Chandigarh Chandigarh, Punjab | |
| Presidio Ospedaliero di Rivoli Rivoli, To | |
| Prisma Health-Midlands Columbia, South Carolina | |
| Private Healthcare Institution - Acibadem Sistina Hospital Skopje Skopje, | |
| Pro Familia Altera Sp. z o.o. Katowice, Silesian Voivodeship | |
| Professor Skride Heart Clinic Riga, | |
| Promotora Medica Las Americas S.A. Medellín, | |
| Providence Med Research Ctr Spokane, Washington | |
| Purushotham & Akther Kotha MD, inc. La Mesa, California | |
| Pusan National University Hospital Busan, | |
| Pusan National University Yangsan Hospital Yangsan, | |
| RYEXO Clinical Research Pretoria, Gauteng | |
| RYEXO Clinical Research Pretoria, Gauteng | |
| Rabin MC Beilinson - Heart Failure Unit Petah Tikva, | |
| Radboudumc Nijmegen, Gelderland | |
| Rakuwakai Marutamachi Hospital_Cardiology Kyoto, | |
| Rama Research LLC Marion, Ohio | |
| Ramathibodi Hospital-Cardiovascular metabolic Center Bangkok, | |
| Rambam MC - Heart Failure Unit Haifa, | |
| Ramesh Hospitals Vijayawada, Andhra Pradesh | |
| Raslouw Private Hospital Pretoria, Gauteng | |
| Reid Physician Associates Richmond, Indiana | |
| Renmin Hospital of Wuhan University-Cardiology Wuhan, Hubei | |
| Republican Siauliai Hospital Consulting Outpatient Clinic Šiauliai, | |
| Rhythm Heart Institute Vadodara, Gujarat | |
| Riga 1st Hospital Riga, | |
| Riga East Clinical University Hospital - Clinic "Gailezers" Riga, | |
| Rikshospitalet - Kardiologisk forskning Oslo, | |
| Roanoke Heart Institute Roanoke, Virginia | |
| Robley Rex VA Medical Center Louisville, Kentucky | |
| Rocky Mountain Regional VAMC Aurora, Colorado | |
| Rodrigo Botero S.A.S Medellín, Antioquia | |
| Royal Adelaide Hospital Cardiovascular Clinical Trials Adelaide, South Australia | |
| Royal Bournemouth Hospital Bournemouth, Dorset | |
| Royal Bournemouth Hospital Bournemouth, Dorset | |
| Royal Brisbane and Women's Hospital Herston, Queensland | |
| Royal Columbian Hospital New Westminster, British Columbia | |
| Royal Devon University Healthcare NHS Foundation Trust Exeter, | |
| Royal Devon University Healthcare NHS Foundation Trust Exeter, | |
| Royal Hobart Hospital Hobart, | |
| Royal University Hospital Saskatoon, Saskatchewan | |
| S Denver Cardiology Associates Littleton, Colorado | |
| S.C. Centrul Medical Unirea S.R.L. Brasov, | |
| S.P. Medical College and A.G. Hospitals Bikaner, Rajasthan | |
| S.P. Medical College and A.G. Hospitals Bikaner, Rajasthan | |
| SC Cardiomed SRL Iași, | |
| SC Consultmed SRL Iași, | |
| SC Diamed Obesity SRL Galati, | |
| SCANMED Spółka Akcyjna Kutno, | |
| SMH Cardiology Clinical Trials Inc. Surrey, British Columbia | |
| SMS Medical College & Attached Hospitals Jaipur, Rajasthan | |
| SMS Medical College & Attached Hospitals Jaipur, Rajasthan | |
| Saga-ken Medical Centre Koseikan_Cardiology Saga, | |
| Sahyadri Clinical Research And Development Center Pune, Maharashtra | |
| Saint Michael's Med Ctr NJ Newark, New Jersey | |
| Saint Michael's Med Ctr NJ Newark, New Jersey | |
| Saiseikai Imabari Hospital Imabari-shi, Ehime, | |
| Saiseikai Imabari Hospital_Cardiology Imabari-shi, Ehime, | |
| Saiseikai Suita Hospital_Cardiovascular Medicine Osaka, | |
| Saiseikai Yokohamashi Nanbu Hospital_Cardiology Yokohama-shi, Kanagawa, | |
| Samodzielny Publiczny Specjalistyczny Szpital Zachodni Im.Sw.Jana Pawla II Grodzisk Mazowiecki, | |
| Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orłowskiego Centrum Medycznego Kształcenia Podyplomowego Warsaw, Masovian Voivodeship | |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych i Administracji w Rzeszowie Rzeszów, Podkarpackie Voivodeship | |
| Samsung Medical Center Seoul, | |
| San Diego Cardiac Center San Diego, California | |
| Sanford Health_Sioux Falls Sioux Falls, South Dakota | |
| Sanford Health_Sioux Falls Sioux Falls, South Dakota | |
| Santa Sp. z o.o. Lodz, | |
| Saratoga Clinical Research Saratoga Springs, New York | |
| Sarawak Heart Centre Kota Samarahan, Sarawak | |
| Sardar Vallabhbhai Patel Institute of Medical Sciences and Research Ahmedabad, Gujarat | |
| Sardar Vallabhbhai Patel Institute of Medical Sciences and Research Ahmedabad, Gujarat | |
| Saul Vizel Pro. Med. Corp Cambridge, Ontario | |
| Sc Sal Med Srl Piteşti, | |
| Scripps Memorial Hospital La Jolla La Jolla, California | |
| Seinäjoen keskussairaala Seinäjoki, | |
| Selma Medical Associates Winchester, Virginia | |
| Selma Medical Associates Winchester, Virginia | |
| Selye János Kórház Komárom, Komárom-Esztergom | |
| Semmelweis Egyetem Városmajori Szív- és Érgyógyászat Budapest, | |
| Sengkang General Hospital Singapore, | |
| Sengupta Hospital and Research Institute Nagpur, Maharashtra | |
| Sengupta Hospital and Research Institute Nagpur, Maharashtra | |
| Sentara Health Research Center Norfolk, Virginia | |
| Seoul National University Bundang Hospital Seongnam-si, | |
| Seoul National University Hospital Seoul, | |
| Seth GS medical college and KEM Hospital Mumbai, Maharashtra | |
| Severance Hospital, Yonsei University Health System Seoul, | |
| Shaanxi Provincial People's Hospital-Cardiology Xi'an, Shaanxi | |
| Shamir MC - Cardio and Pedi Beer Yaakov, | |
| Shanghai Xuhui Central Hospital Shanghai, | |
| Shanghai Xuhui Central Hospital Shanghai, | |
| Sheba MC - Cardiology Clinical Research Unit Tel Litwinsky, | |
| Shenzhen People's Hospital Shenzhen, | |
| Sherman Clinical Research Sherman, Texas | |
| Shop#1 Health Emporium Midrand, Gauteng | |
| Showa University Fujigaoka Hospital_Cardiology Yokohama, Kanagawa | |
| Shri B. D. Mehta Mahavir Heart Institute Surat, Gujarat | |
| Shri B. D. Mehta Mahavir Heart Institute Surat, Gujarat | |
| Shri Krishna Hrudayalaya & Critical Care Centre Nagpur, Maharashtra | |
| Shri Krishna Hrudayalaya & Critical Care Centre Nagpur, Maharashtra | |
| Shri Mahant Indiresh Hospital Dehradun, Uttarakhand | |
| Siddhartha Medical College & Government General Hospital Vijaywada, Andhra Pradesh | |
| Siping Central People's Hospital Siping, Jilin | |
| Sir Ganga Ram Hospital-Cardiology New Delhi, | |
| Siriraj Hospital Bangkok, | |
| Sjællands Universitetshospital_Roskilde Roskilde, | |
| Slaskie Centrum Chorob Serca w Zabrzu Zabrze, Silesian Voivodeship | |
| Sociedade Hospitalar Angelina Caron, Brazil Campina Grande do Sul, Paraná | |
| Somogy Megyei Kaposi Mor Oktato Korhaz Kaposvár, Somogy County | |
| Songklanagarind Hospital Songkhla, | |
| Songklanagarind Hospital Songkhla, | |
| Sourasky MC - Cardio Vascular Research Center Tel Aviv, | |
| South Oklahoma Heart Research, LLC Oklahoma City, Oklahoma | |
| Southmead Hospital Bristol, | |
| Southmead Hospital Bristol, | |
| Specijalna bolnica Krapinske Toplice - Kardiologija Krapinske Toplice, Krapinsko Zagorska County | |
| Specijalna bolnica Medico Rijeka, | |
| Specjalistyczna Praktyka Lekarska L. Bryniarski Krakow, | |
| Spedali Civili Brescia Brescia, Bs | |
| Spital Judetean De Urgenta Satu Mare Satu Mare, | |
| Spitalul Clinic Judetean De Urgenta Bihor Oradea, | |
| Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta Constanța, | |
| Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta Constanța, | |
| Spitalul Clinic Judetean De Urgenta Targu Mures Târgu Mureş, | |
| Spitalul Clinic Judetean de Urgenta Brasov Brasov, | |
| Spitalul Clinic Municipal de Urgenta Timisoara Timișoara, | |
| Spitalul Clinic de Urgenta "Sf. Ioan" Bucuresti Bucharest, | |
| Spitalul Judetean de Urgenta Braila Brăila, | |
| Spitalul Universitar de Urgenta Bucuresti Bucharest, | |
| Spitalul Universitar de Urgență Elias Bucharest, | |
| Sri Jayadeva Institute of Cardiovascular Sciences & Research Bengaluru, Karnataka | |
| Sri Jayadeva Institute of Cardiovascular Sciences & Research Bengaluru, Karnataka | |
| Srinagarind Hospital Khon Kaen, | |
| St George's Hospital Tooting, London | |
| St George's Hospital Tooting, London | |
| St James's CRF Dublin, | |
| St James's CRF Dublin, | |
| St Johns Ctr Clin Rsch-St. Aug Saint Augustine, Florida | |
| St Louis Heart & Vascular, P.C. St Louis, Missouri | |
| St Pauls Hospital Vancouver, British Columbia | |
| St. Boniface Hospital Winnipeg, Manitoba | |
| St. Joseph's Hospital Tampa, Florida | |
| St. Luke's Idaho Cardiology Associates Meridian, Idaho | |
| St. Michael's Hospital_Toronto Toronto, Ontario | |
| St. Richards Hospital Chichester, West Sussex | |
| St. Richards Hospital_Cardiology Chichester, West Sussex | |
| Stanford Univ School of Med Palo Alto, California | |
| Stavanger Universitetssykehus, Helse Stavanger HF Stavanger, | |
| Stony Brook University Hospital Stony Brook, New York | |
| StudyCor Jyväskylä, | |
| Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University Guangzhou, | |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen Universtiy Guangzhou, Guangdong | |
| Sunpasitthiprasong Hospital Ubon Ratchathani, | |
| Swedish Medical Center_Seattle Seattle, Washington | |
| Swedish Medical Center_Seattle Seattle, Washington | |
| Sydney Cardiometabolic Centre Liverpool, New South Wales | |
| Synexus Helderberg Clinical Research Centre Somerset West, Western Cape | |
| Synexus Helderberg Clinical Research Centre Somerset West, Western Cape | |
| Synexus Watermeyer Clinical Research Centre Pretoria, Gauteng | |
| Szegedi Tudomanyegyetem Szeged, | |
| Szegedi Tudományegyetem II. sz Belgyógyászati és Kardiológia Szeged, Csongrád-Csanád | |
| Szpital Miejski w Gliwicach Sp. z o.o. Gliwice, | |
| Szpital Św. Anny w Miechowie Miechów, | |
| Szpitale Powiatowe Sp. z o.o. Łask, | |
| TYKS Sydänkeskus Turku, | |
| Tagore Medical Center Balatonfüred, | |
| Taichung Veterans General Hospital Taichung, | |
| Taipei Medical University Hospital Taipei, | |
| Taipei Veterans General Hospital Taipei, | |
| Taipei Veterans General Hospital Taipei, | |
| Tan Tock Seng Hospital Singapore, | |
| Tartu University Hospital Tartu, | |
| Tays Sydänsairaala Tampere, | |
| Tennova HC Turkey Creek MC Knoxville, Tennessee | |
| Texas Heart Inst Medical Ctr Houston, Texas | |
| Texas Institute of Cardiology PA McKinney, Texas | |
| Thammasat Hospital Pathum Thani, | |
| Thammasat University Hospital Klong Luang, Pathumthani, Changwat Pathum Thani | |
| The Affiliated Hospital of Jiangsu University Zhenjiang, Jiangsu | |
| The Affiliated Hospital of Jining Medical University-Cardiology Jining, Shandong | |
| The Affiliated Hospital of Xuzhou Medical University-Cardiology Xuzhou, Jiangsu | |
| The Affiliated Hospital of Xuzhou Medical University-Cardiology Xuzhou, Jiangsu | |
| The Canberra Hospital_Garran Garran, Australian Capital Territory | |
| The Catholic University of Korea, Seoul St. Mary's Hospital Seoul, | |
| The First Affiliated Hospital of Chongqing Medical University-Cardiology Chongqing, Chongqing Municipality | |
| The First Affiliated Hospital of Harbin Medical University-Cardiovascular Harbin, Heilongjiang | |
| The First Affiliated Hospital of Jinan University Guangzhou, Guangdong | |
| The First Affiliated Hospital of Soochow University Suzhou, | |
| The First Affiliated Hospital of Soochow University Suzhou, | |
| The First Affiliated Hospital of WMU-Cardiology Wenzhou, Zhejiang | |
| The First Affiliated Hospital of Xi'an Jiaotong University-Cardiovascular Xi'an, Shaanxi | |
| The First Affiliated Hospital of Zhejiang University School of Medicine Hangzhou, Zhejiang | |
| The First Hospital of Anhui University of Science & Technology (Huainan First People's Hospital)-Cardiology Huainan, Anhui | |
| The First Hospital of Hebei Medical University-Cardiovascular Shijiazhuang, Hebei | |
| The First People's Hospital of Changzhou Changzhou, | |
| The Heartbeat Trust Dublin, | |
| The Jackson Clinic, PA Jackson, Tennessee | |
| The Madras Medical Mission Chennai, Tamil Nadu | |
| The People's Hospital of Guangxi Zhuang Autonomous Region Nanning, Guangxi | |
| The People's Hospital of Liaoning Province-Cardiology Shenyang, Liaoning | |
| The Queen's Medical Center Honolulu, Hawaii | |
| The Research Group of Lexington LLC Lexington, Kentucky | |
| The Royal Oldham Hospital_Cardiology Outpatients Dept. Oldham, | |
| The Second Affiliated Hospital Of Chongqing Medical University Chongqing, Chongqing Municipality | |
| The Second Affiliated Hospital of Nanchang University-Cardiology Nanchang, Jiangxi | |
| The Second Affiliated Hospital of Nanjing Medical university Nanjing, | |
| The Second Affiliated Hospital of Shantou University Medical College-Cardiovascular Shantou, Guangdong | |
| The Second Hospital & Clinical Medical School, Lanzhou University-Internal Medicine & Cardiovascular Lanzhou, Gansu | |
| The Third Xiangya Hospital of Central South University Changsha, Hunan | |
| The Univ. of Tokyo Hp., Dept. of Cardiovascular Medicine Bunkyo-ku, Tokyo, | |
| The University of Osaka Hospital_Cardiovascular medicine Osaka, | |
| The Valley Hosptial Ridgewood, New Jersey | |
| The Valley Hosptial Ridgewood, New Jersey | |
| Thomas Jefferson University_Philadelphia Philadelphia, Pennsylvania | |
| Tianjin Chest Hospital Tianjin, TJ | |
| Tianjin Union Medical Center Tianjin, Tianjin Municipality | |
| Tiervlei Trial Centre Cape Town, Western Cape | |
| Tohoku Medical and Pharmaceutical University Hospital_Division of Cardiology Miyagi, | |
| Tokai University Hospital_Cardiology Kanagawa, | |
| Tokyo Shinagawa Hospital_Cardiovascular Medicine Tokyo, | |
| Tokyo-Eki Center-building Clinic_Internal Medicine Tokyo, | |
| Tongji Hospital of Tongji University-Cardiology Shanghai, Shanghai Municipality | |
| Tottori University Hospital_Cardiovascular Medicine Tottori, | |
| Townsville University Hospital Douglas, | |
| Toyama University Hospital_Internal Medicine 2 Toyama, | |
| Trakya University Edirne, | |
| Tread Research (Pty)Ltd Cape Town, Western Cape | |
| Treant zorggroep Emmen, | |
| Trinity Health Michigan Heart Ypsilanti, Michigan | |
| Tzaneio General Hospital of Piraeus Piraeus, | |
| U.G.H of Athens "Attikon" Chaidari, Athens, | |
| UCI Health Orange, California | |
| UKC Ljubljana, Cardiology department Ljubljana, | |
| UKC Maribor - cardiology Maribor, | |
| UKC Maribor - cardiology Maribor, | |
| UMC Groningen Groningen, | |
| UMHAT "Dr. Georgi Stranski" Pleven Pleven, | |
| UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Cardiology Plovdiv, | |
| UNC Cardiology Outpatient Ctr Chapel Hill, North Carolina | |
| UNC Rex Healthcare Raleigh, North Carolina | |
| UT Physicians - Houston Medical Center Houston, Texas | |
| UTD SW Medical Center-Dallas Dallas, Texas | |
| UZ Brussel Jette, | |
| UZA - UZ Antwerpen - Cardiology Department Edegem, | |
| Uni-Med. Göttingen - Kardiologie, Pneumologie Göttingen, | |
| UniCardia & UniMedica & UniEstetica Krakow, | |
| Unidad de Estudios Clínicos de la Fundación Cardiovascular de Colombia Bucaramanga-piedecuesta, Valle Del Menzuli - Santander, Santander Department | |
| Unidade Local De Saude Da Guarda E.P.E. - Hospital Sousa Martins Guarda, | |
| Unidade Local De Saude Da Regiao De Leiria E.P.E.- Hospital de Santo André Leiria, | |
| Unidade Local De Saude De Lisboa Ocidental E.P.E. - Hospital São Francisco Xavier Lisbon, | |
| Unidade Local De Saude De Santa Maria E.P.E. Lisbon, | |
| Unidade Local De Saude de Tâmega e Sousa E.P.E. Guilhufe - Penafiel, | |
| Unidade Local Saúde Baixo Mondego, E.P.E. - Hospital Distrital Figueira Da Foz E.P.E. Figueira da Foz Municipality, | |
| Unidade Local de Saúde Entre Douro e Vouga E.P.E. - Hospital São Sebastião Santa Maria da Feira, | |
| Unidade Local de Saúde da Arrábida, E.P.E. Setúbal, | |
| Unidade Local de Saúde de Santo António, E.P.E Porto, | |
| Unidade de Local de Saúde de Braga Braga, | |
| Unidade de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo Ribeirão Preto, São Paulo | |
| Uniklinik Aachen - Med. Klinik I Aachen, | |
| Uniklinik Jena - Kardiologie Jena, | |
| Uniklinik Klinikum Bielefeld - Kardiologie und Internist. Intensivmedizin Bielefeld, | |
| Uniklinik TU Dresden - Herzzentrum Dresden GmbH Dresden, | |
| Uniklinikum Salzburg Kardiologie Salzburg, | |
| Univ Gen Hospital Larisa, Cardiology Medicine Clinic Larissa/Thessaly, Greece | |
| Univ. of Nebraska Medical Center_Omaha Omaha, Nebraska | |
| Universidade Federal de São Paulo - UNIFESP São Paulo/SP, | |
| Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz Würzburg, | |
| Universiti Teknologi MARA, Sungai Buloh Campus Sungai Buloh, Selangor | |
| University Clinical Centre Kragujevac Kragujevac, | |
| University Clinical Centre Nis, Clinic for Cardiology Niš, | |
| University Clinical Centre Sarajevo Sarajevo, | |
| University Clinical Centre of the Republic Srpska Banja Luka, | |
| University Hospital Aintree Liverpool, | |
| University Hospital Centre Zagreb Zagreb, City of Zagreb | |
| University Hospital Centre Zagreb Zagreb, City of Zagreb | |
| University Hospital Hairmyres - Cardiology East Kilbride, South Lanarkshire | |
| University Hospital Monklands - Cardiology Research Airdrie, Lanarkshire | |
| University Hospital Sveti Duh Zagreb, | |
| University Malaya Medical Centre Kuala Lumpur, | |
| University Medical Center Hamburg-Eppendorf Hamburg, City state of Hamburg | |
| University Medical Center New Orleans New Orleans, Louisiana | |
| University at Buffalo_Erie County Med Ctr Buffalo, New York | |
| University of Calgary_Calgary Calgary, Alberta | |
| University of Iowa Hospitals and Clinics Iowa City, Iowa | |
| University of Louisville Louisville, Kentucky | |
| University of Michigan Medicine Ann Arbor, Michigan | |
| University of North Tees Hospital Stockton-on-Tees, | |
| University of North Tees Hospital Stockton-on-Tees, | |
| University of Vermont Medical Center Burlington, Vermont | |
| University of Virginia Charlottesville, Virginia | |
| Universitätsklinikum Frankfurt aM - Kardiologie Frankfurt am Main, | |
| Universitätsklinikum Freiburg - Medical Center Freiburg im Breisgau, | |
| Universitätsklinikum Hamburg-Eppendorf - University Medical Center Hamburg-Eppendorf Hamburg, | |
| Universitätsklinikum Leipzig - Klinik und Poliklinik für Kardiologie Leipzig, | |
| Universitätsklinikum des Saarlandes - Innere Med. III Homburg, | |
| Uniwersytecki Szpital Kliniczny im. J.Mikulicza-Radeckiego Wroclaw, Lower Silesian Voivodeship | |
| Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Łodzi Lodz, | |
| Uniwersytecki Szpital Kliniczny w Bialymstoku K. Kardio Bialystok, Podlaskie Voivodeship | |
| Uwajima City Hospital_ Cardiology Uwajima-shi, Ehime | |
| VA Greater Los Angeles Hlthcare System Los Angeles, California | |
| VA Loma Linda Hlthcr Sys Loma Linda, California | |
| VA Medical Center_Salem Salem, Virginia | |
| VMMC & Safdarjung Hospital New Dehli, New Delhi | |
| Vajira Hospital - Cardio Bangkok, | |
| Valley Clinical Trials Covina, California | |
| Valley Clinical Trials, Inc. Northridge, California | |
| Valley Health Link Winchester, Virginia | |
| Velocity - Clinical Research Germany GmbH Berlin, | |
| Venizeleio Pananeio Heraklion, | |
| Veritas Hospital_Cardiology Hyōgo, | |
| Viacar Recherche Clinique Inc. Longueuil, Quebec | |
| Victoria Heart Institute Foundation Victoria, British Columbia | |
| Vilnius University Hospital Santaros Klinikos Vilnius, | |
| Virginia Commonwealth University Richmond, Virginia | |
| Virginia Heart Falls Church, Virginia | |
| Virginia Mason Medical Center Seattle, Washington | |
| Vita Longa Sp. z o. o. Katowice, | |
| Vita Longa Sp. z o. o. Katowice, | |
| Vseobecna kardiologicka ambulance Tábor, | |
| Vseobecna kardiologicka ambulance Tábor, | |
| Všeobecná kardiologická ambulance s.r.o. Tábor, | |
| WVU Heart & Vascular Institute Morgantown, West Virginia | |
| William S Middleton Mem VA Hosp Madison, Wisconsin | |
| Winchester Dist Memorial Hosp Winchester, Ontario | |
| Winter Haven Hospital Winter Haven, Florida | |
| Witham Health Services Lebanon, Indiana | |
| Wits Bara Clinical Trial Site Johannesburg, Gauteng | |
| Wits Clinical Research Johannesburg, Gauteng | |
| Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu Przemyśl, | |
| Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu Torun, Kuyavian-Pomeranian Voivodeship | |
| Wojewódzki Specjalistyczny Szpital im.Wl. Bieganskiego, Lodz, | |
| Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw, | |
| Women's College Hospital Toronto, | |
| Wonju Severance Christian Hospital Gangwon-do, | |
| Wuhan Asia Heart Hospital-Department of Cardiovascular Wuhan, Hubei | |
| Wycombe General Hospital High Wycombe, | |
| Yao Tokushukai General Hospital_Cardiovascular division Osaka, | |
| Yokohama Minami Kyousai Hospital_Cardiology Kanagawa, | |
| York Clinical Research LLC Norfolk, Virginia | |
| Zane Lucane GP Practice Grobiņa, South Kurzeme Municipality | |
| Zdrowie S.C. Agnieszka I Donald Drożdż Wroclaw, Lower Silesian Voivodeship | |
| Zemgales diabetes centre Jelgava, | |
| Zentrum fuer klinische Studien Suedbrandenburg GmbH Elsterwerda, | |
| Zhejiang Provincial People's Hospital Hangzhou, | |
| Zhongda Hospital Southeast University Nanjin, | |
| Ziekenhuis Oost-Limburg AV - Cardiology Genk, | |
| Zupanijska bolnica Cakovec Čakovec, | |
| Zuyderland ziekenhuis Heerlen, | |
| i9 Pesquisas Clínicas Campinas, São Paulo | |
| zero PRAXEN Mannheim-Schwetzingerstadt Mannheim, | |
| Észak-Pesti Centrumkórház Honvédkórház Budapest, |
A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation (ATHENA)
Novo Nordisk - clinicaltrials@novonordisk.com
NCT06200207
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 milligrams per liter (mg/L) at screening (visit 1)
* Disease specific - cardiovascular:
* N-terminal-pro-brain natriuretic peptide (NT-proBNP) greater than or equal to 225 picograms per milliliter (pg/mL) (375 pg/mL for participants with atrial fibrillation/flutter) at screening
* Diagnosis of heart failure (New York heart association (NYHA) Class II-III)
* Left ventricular ejection fraction (LVEF) greater than 40 percent documented by echocardiography within 12 months prior to or at screening (visit 1). The LVEF must be documented in medical records and the most recent measurement must be used to determine eligibility with no interim event signalling potential deterioration in ejection fraction (example myocardial infarction (MI) or heart failure (HF) hospitalisation)
* Structural heart disease and/or functional heart disease documented by echocardiography within 12 months prior to or at screening (visit 1) showing at least one of the following:
• Left atrial (LA) volume index greater than 34 milliliter per square meter (mL/m\^2)
• LA diameter greater than or equal to 3.8 centimeter (cm)
• LA length greater than or equal to 5.0 cm
• LA area greater than or equal to 20 square centimeter (cm\^2)
• LA volume greater than or equal to 55 milliliter (mL)
• Intraventricular septal thickness greater than or equal to 1.1 cm
• Posterior wall thickness greater than or equal to 1.1 cm
• LV mass index greater than or equal to 115 gram per square meter (g/m\^2) in men or greater than or equal to 95 g/m\^2 in women h) E/e' (mean septal and lateral) greater than or equal to 10 i) e' (mean septal and lateral) less than 9 centimeter per second (cm/s) * No heart failure hospitalisations or urgent heart failure visits between screening and randomisation * Able to perform the 6-minute walk test (6MWT) at screening with a minimum distance of 100 metres * Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score lesser than 80 at screening
Exclusion Criteria:
* Medical conditions - cardiovascular:
* Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart failure hospitalisation within 30 days prior to screening (visit 1)
* Systolic blood pressure greater than or equal to 180 millimeters of mercury (mmHg) at screening (visit 1). If the systolic blood pressure is 160-179 mmHg, the patient should be receiving greater than or equal to 3 antihypertensive drugs
* Heart rate above 110 or below 40 beats per minute as evaluated on the Electrocardiogram (ECG) performed at screening (visit 1)
* Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1)
* Planned cardiac device or atrial flutter/atrial fibrillation ablation procedure known during the screening period (visit 1)
* Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomisation (visit 2) or any major surgical procedure planned at the time of randomisation (visit 2)
* Heart failure due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, uncorrected more than moderate primary valve disease
* Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including chronic obstructive pulmonary disease (COPD)
* Any other condition judged by the investigator that could account for heart failure symptoms and signs (e.g., anaemia, hypothyroidism)
* Medical conditions - infections/immunosuppression:
* Clinical evidence of, or suspicion of, active infection at the discretion of the investigator DRUG: Ziltivekimab, DRUG: Placebo
Heart Failure, Systemic Inflammation
I'm interested
Share via email
Show 236 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| "AHEPA" University General Hospital of Thessaloniki Thessaloniki, | |
| "Hygeia" General Hospital of Athens Athens, | |
| "Laiko" General Hospital of Athens Athens, | |
| "Medical Center Hera" EOOD - Sofia Sofia, | |
| "UMHAT "Sveta Anna" Sofia" AD, Clinic of Cardiology Sofia, | |
| "UMHATEM N.I. Pirogov" EAD Sofia, | |
| 'G. Gennimatas' General Hospital of Athens Athens, | |
| 'G. Gennimatas' General Hospital of Athens Athens, | |
| 'Ippokrateio' General Hospital of Thessaloniki Thessaloniki, | |
| 10 Wojskowy Szpital Kliniczny z Polikliniką - Samodzielny Publiczny Zakład Opieki Zdrowotnej w Bydgoszczy Bydgoszcz, | |
| 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu Wroclaw, Lower Silesian Voivodeship | |
| AMS Cardiology Horsham, Pennsylvania | |
| Advanced Cardiovascular, LLC Alexander City, Alabama | |
| Advara Heartcare Mulgrave, Victoria | |
| Afyonkarahisar Health Sciences University Afyonkarahisar, | |
| Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Kardiyoloji Afyonkarahisar, | |
| Alexandra General Hospital, Therapeutic Clinic Athens, | |
| All India Institute of Medical Sciences (AIIMS) New Delhi, National Capital Territory of Delhi | |
| All India Institute of Medical Sciences (AIIMS), Bhubaneswar Bhubaneswar, Odisha | |
| All India Institute of Medical Sciences (AIIMS), Nagpur Nagpur, Maharashtra | |
| American Heart of Poland S.A. Zgierz, | |
| American Heart of Poland S.A. Zgierz, | |
| Ankara Sehir Hastanesi Cardiology Ankara, | |
| Ankara Sehir Hastanesi Cardiology Ankara, | |
| B M Birla Heart Research Centre Kolkata, West Bengal | |
| Ballarat Base Hospital Ballarat, Victoria | |
| Ballarat Base Hospital Ballarat, Victoria | |
| Basaksehir Cam ve Sakura Sehir Hastanesi Istanbul, | |
| Bursa Şehir Hastanesi- Kardiyoloji Bursa, | |
| CHLO, EPE - Hospital São Francisco Xavier Lisbon, | |
| CHTâmega e Sousa - Hospital Padre Américo Guilhufe - Penafiel, | |
| CHU de Quebec-Uni Laval-Hotel Québec, | |
| CIPREC Pueyrredon Buenos Aires, | |
| CPS Research Waterloo, Ontario | |
| CPS Research Waterloo, Ontario | |
| Cambridge Cardiac Care Centre Cambridge, Ontario | |
| Cardio and Vascular Assoc-CAVA Bloomfield Hills, Michigan | |
| Cardiology & Medicine Clinic Little Rock, Arkansas | |
| Cardiología Palermo City of Buenos Aires, Buenos Aires | |
| Cardiomedicum Sp. z o.o. Krakow, Lesser Poland Voivodeship | |
| Cardiomedicum Sp. z o.o. Krakow, Lesser Poland Voivodeship | |
| Centre Hospitalier Intercommunal Toulon La Seine-Sur-Mer - Hopital Sainte Musse Toulon, | |
| Centre Hospitalier Regional Universitaire de Tours-Hopital Trousseau Chambray-lès-Tours, | |
| Centre Hospitalier Universitaire de Poitiers Poitiers, | |
| Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou Rennes, | |
| Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle Rouen, | |
| Centro Cardiovascular Salta Salta, | |
| Centro Hospitalar Lisboa Norte Lisbon, | |
| Centro Hospitalar de Setubal Setúbal, | |
| Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli Buenos Aires, | |
| Centro Médico CIMEL Lanús Este, Buenos Aires | |
| Centro de Investigación y Prevención Cardiovascular CABA, | |
| Centrum Medyczne Intercor Sp. z o.o. Bydgoszcz, Kuyavian-Pomeranian Voivodeship | |
| Chicago Medical Research LLC Hazel Crest, Illinois | |
| Chopda Medicare and Research Centre Pvt. Ltd. Nashik, Maharashtra | |
| Chopda Medicare and Research Centre Pvt. Ltd. Nashik, Maharashtra | |
| Chru de Nancy - Hopital Brabois Vandœuvre-lès-Nancy, | |
| Clearwater Cardiovascular Consultants Largo, Florida | |
| Clearwater Cardiovascular Consultants Largo, Florida | |
| Clinical Advancement Ctr, PLLC San Antonio, Texas | |
| Clinical Advancement Ctr, PLLC San Antonio, Texas | |
| Clinical Research Solutions Inc. Waterloo, Ontario | |
| Clínica Nuevas Tecnologías en Diabetes y Endocrinología Seville, | |
| Complejo Hospitalario Universitario de Santiago Santiago de Compostela, | |
| Consultorio Integral de Atención al Diabético Morón, | |
| Corcare Cardiovascular Research Scarborough Village, Ontario | |
| David Turbay, MD, PLLC El Paso, Texas | |
| Diabetes Heart Research Centre Toronto, Ontario | |
| Diabetes Heart Research Centre Toronto, Ontario | |
| Dr. Ram Manohar Lohia Institute of Medical Sciences Lucknow, Uttar Pradesh | |
| Eastern Shore Rsrch Inst, LLC Fairhope, Alabama | |
| Erciyes University Cardiology Kayseri, | |
| Erciyes University Cardiology Kayseri, | |
| Eskisehir Osmangazi University Sağlık Uygulama ve Arastirma Eskişehir, Odunpazari | |
| Evangelismos Hospital Athens, | |
| Fiona Stanley Hospital Cardiology Murdoch, Western Australia | |
| Formed 2 Sp. z o.o. Oświęcim, Lesser Poland Voivodeship | |
| Fundación para la Investigación del Hospital Clínico de Valencia (INCLIVA) Valencia, | |
| Futuremeds Birmingham, | |
| G B Pant Institute of Postgraduate Medical Education and Research New Delhi, National Capital Territory of Delhi | |
| G B Pant Institute of Postgraduate Medical Education and Research New Delhi, National Capital Territory of Delhi | |
| GA Arrhythmia Cons & Rsch Inst Macon, Georgia | |
| Ganesh Shankar Vidyarthe Memorial (GSVM) Medical College Kanpur, Uttar Pradesh | |
| Ganesh Shankar Vidyarthe Memorial (GSVM) Medical College Kanpur, Uttar Pradesh | |
| Gen Hospital of Thessaloniki G.Papanikolaou,Cardiology Dpt Thessaloniki, | |
| General Hospital of Chalkida Chalcis, | |
| General Hospital of Chios "Skilitsio" Chios, | |
| Gesundheitscentrum Mainz (Regner / Schmitt) Mainz, | |
| Guru Nanak CARE Hospitals Hyderabad, Telangana | |
| Hospital Gregorio Maranon Madrid, | |
| Hospital Raja Perempuan Zainab II Kelantan, | |
| Hospital Raja Perempuan Zainab II Kelantan, | |
| Hospital Raja Permaisuri Bainun Ipoh Ipoh, Perak | |
| Hospital Ramon Y Cajal Madrid, | |
| Hospital Serdang Kajang, Selangor | |
| Hospital Sultanah Aminah Johor Bahru, Johor | |
| Hospital Sultanah Aminah Johor Bahru, Johor | |
| Hospital Sultanah Bahiyah Alor Setar, Kedah, | |
| Hospital Tengku Ampuan Afzan Kuantan, Pahang | |
| Hospital Universitario Puerta de Hierro Majadahonda Majadahonda, | |
| Hospital Universitario de Salamanca Salamanca, | |
| Hospital Universitario de Salamanca Salamanca, | |
| Hospital Virgen del Camino - Sanlúcar de Barrameda Sanlúcar de Barrameda, | |
| Hospital Vithas Sevilla Seville, | |
| Hospital da Luz Lisbon, | |
| Illawarra Heart Health Centre Wollongong, New South Wales | |
| Ind. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman Gdynia, Pomeranian Voivodeship | |
| Innera s.r.o. Benešov, | |
| Institut de Cardiologie de Montreal Montreal, Quebec | |
| Instituto de Investigaciones Clinicas Quilmes SRL Buenos Aires, | |
| Investigaciones Clínicas Tucumán San Miguel de Tucumán, Tucumán., | |
| Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) Puducherry, Tamil Nadu | |
| Jawaharlal Nehru Medical College and Hospital Aligarh, Uttar Pradesh | |
| Jawaharlal Nehru Medical College and Hospital Aligarh, Uttar Pradesh | |
| John Hunter Hospital New Lambton Heights, New South Wales | |
| John Hunter Hospital - Cardiovascular Department New Lambton Heights, New South Wales | |
| KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre Karnataka, | |
| KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre Karnataka, | |
| Kansas City VA Medical Center Kansas City, Missouri | |
| Kansas City VA Medical Center Kansas City, Missouri | |
| Kardio Life Włocławek, Kuyavian-Pomeranian Voivodeship | |
| Kardio Life Włocławek, Kuyavian-Pomeranian Voivodeship | |
| Kardiologicka ambulance Brno s.r.o. Brno, | |
| Kardiologie Trutnov Ferkl Trutnov, | |
| Kardiologisch-Angiologische Praxis Herzzentrum Bremen Bremen, | |
| Kardiopraxis Schirmer Kaiserslautern, | |
| Kasturba Medical College and Hospital, Manipal Udupi, Karnataka | |
| Kasturba Medical College and Hospital, Manipal Udupi, Karnataka | |
| Kath. Hospitalvereinigung Thüringen gGmbH - KKH St. Johann Nepomuk - Innere Med. II Erfurt, | |
| King George Hospital Visakhapatnam, Andhra Pradesh | |
| Kocaeli Universitesi Tip Fakultesi Hastanesi Kocaeli, | |
| Konstantopouleio G.H. of Athens, "Agia Olga" Athens, | |
| Linden sp. z o.o. sp. k. Krakow, Lesser Poland Voivodeship | |
| Long Island Cardiovascular Consultants PC Lake Success, New York | |
| MD Medical Research Oxon Hill, Maryland | |
| MEDICON a.s. Prague, | |
| MHAT "Puls" AD Cardiology Department Blagoevgrad, | |
| MHAT Haskovo AD Haskovo, | |
| MHAT Heart and Brain Pleven, | |
| MVZ CCB Frankfurt Und Main-Taunus GbR Frankfurt, | |
| MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien Fulda, | |
| Malla Reddy Narayana Multispeciality Hospital Hyderabad, Telangana | |
| Manipal Hospital, Mysuru Mysuru, Karnataka | |
| Maryland Cardiovascular Specialists - Baltimore Baltimore, Maryland | |
| Medical Center Synexus Sofia Sofia, | |
| Medical center ISUL - Tsaritsa Yoanna EOOD Sofia, | |
| Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A. Athens, | |
| Millennium Cardiology Farmington Hills, Michigan | |
| Montreal General Hospital Montreal, Quebec | |
| Mount Sinai Hosp at NYC New York, New York | |
| Naval Hospital of Athens Athens, | |
| Naval Hospital of Athens Athens, | |
| Nemocnice AGEL Třinec-Podlesí a.s. Třinec, | |
| Ninewells Hospital Dundee, | |
| Northwell Health Phys Cardio Riverhead, New York | |
| Northwest Heart Center Tomball, Texas | |
| Ocala Cardiovascular Research Ocala, Florida | |
| Ordinace pro choroby srdce Chomutov, | |
| Ormond Beach Clinical Research Ormond Beach, Florida | |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji Warsaw, | |
| Peterborough City Hospital Peterborough, PTE | |
| PharmaTex Research Amarillo, Texas | |
| PharmaTex Research Amarillo, Texas | |
| Polyclinique Vauban Valenciennes, | |
| Pratia S.A. Jelenia Góra, Lower Silesian Voivodeship | |
| Private Practice Leadership LLC. Katy, Texas | |
| Prywatna Praktyka Lekarska Anna Chudoba Żyrardów, Masovian Voivodeship | |
| Raigmore Hospital Inverness, | |
| Rajiv Gandhi Super Speciality Hospital New Delhi, National Capital Territory of Delhi | |
| Renown Regional Medical Center Reno, Nevada | |
| Rhythm Heart Institute Vadodara, Gujarat | |
| S.P. Medical College & Associated Group of Hospitals Bikaner, Rajasthan | |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Pulawach Puławy, Lublin Voivodeship | |
| Sanatorio Esperanza Esperanza, Santa Fe, | |
| Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow, Uttar Pradesh | |
| Saul Vizel Pro. Med. Corp Cambridge, Ontario | |
| Sengupta Hospital and Research Institute Nagpur, Maharashtra | |
| Sentara Health Research Center Norfolk, Virginia | |
| Sherman Clinical Research Sherman, Texas | |
| Siddhartha Medical College & Government General Hospital Vijaywada, Andhra Pradesh | |
| Sir Ganga Ram Hospital New Delhi, National Capital Territory of Delhi | |
| Sismanogleio General Hospital Marousi, | |
| South California Heart Spc Pasadena, California | |
| Sri Jayadeva Institute of Cardiovascular Sciences & Research Bengaluru, Karnataka | |
| Sri Jayadeva Institute of Cardiovascular Sciences & Research Bengaluru, Karnataka | |
| St John's Medical College Hospital Bengaluru, Karnataka | |
| St John's Medical College Hospital Bengaluru, Karnataka | |
| St Johns Ctr Clin Rsch-St. Aug Saint Augustine, Florida | |
| St. Richards Hospital_Cardiology Chichester, West Sussex | |
| Svitavska nemocnice Kardiologie Svitavy, | |
| Szpitale Pomorskie Sp. z o.o. Gdynia, Pomeranian Voivodeship | |
| Szpitale Pomorskie Sp. z o.o. Gdynia, Pomeranian Voivodeship | |
| T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan Adana, | |
| T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan Adana, | |
| The Canberra Hospital_Garran Garran, Australian Capital Territory | |
| The Cardiologists Pty Ltd Epping, Victoria | |
| The Cardiologists Pty Ltd Epping, Victoria | |
| The Prince Charles Hospital Chermside, Queensland | |
| The Prince Charles Hospital Chermside, Queensland | |
| Trakya University Edirne, | |
| Trakya University Edirne, | |
| Trialmed Sp. z o. o. Piotrkow Trybunalski, | |
| Trialmed Sp. z o. o. Piotrkow Trybunalski, | |
| U.G.H of Athens "Attikon" Chaidari, Athens, | |
| U.G.H of Athens "Attikon" Chaidari, Athens, | |
| UCI Health Orange, California | |
| UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Cardiology Plovdiv, | |
| Uniklinik TU Dresden - Herzzentrum Dresden GmbH Dresden, | |
| Univ Gen Hospital Larisa, Cardiology Medicine Clinic Larissa/Thessaly, Greece | |
| University Malaya Medical Centre Kuala Lumpur, | |
| University Malaya Medical Centre Kuala Lumpur, | |
| University of Calgary_Calgary Calgary, Alberta | |
| University of North Carolina at Chapel Hill Chapel Hill, North Carolina | |
| University of Pennsylvania Hospital Philadelphia, Pennsylvania | |
| University of Texas Southwestern Medical Center Dallas, Texas | |
| Universitätsklinikum Freiburg - Medical Center Freiburg im Breisgau, | |
| Universitätsklinikum des Saarlandes - Innere Med. III Homburg, | |
| Uniwersytecki Szpital Kliniczny W Poznaniu Poznan, | |
| Uniwersytecki Szpital Kliniczny W Poznaniu Poznan, | |
| Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Łodzi Lodz, | |
| Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok, | |
| Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok, | |
| UofL Health Care Outpatient Louisville, Kentucky | |
| Valley Clinical Trials, Inc. Northridge, California | |
| Valley Clinical Trials, Inc. Northridge, California | |
| Vardhaman Mahavir Medical College & Safdarjung Hospital New Delhi, National Capital Territory of Delhi | |
| Velocity Clin Rsrch - Savannah Savannah, Georgia | |
| Vijan Hospital & Research Centre Nashik, Maharashtra | |
| Vijan Hospital & Research Centre Nashik, Maharashtra | |
| Villoo Poonawalla Memorial Hospital Pune, Maharashtra | |
| Virginia Commonwealth University Richmond, Virginia | |
| Vojenská nemocnice Brno p.o. Brno, | |
| Washington University St Louis, Missouri | |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika Lodz, Łódź Voivodeship | |
| Zanamed Medical Clinic Sp. z o.o. Lublin, | |
| Zentrum fuer klinische Studien Suedbrandenburg GmbH Elsterwerda, |
The CONFORM Pivotal Trial
Aly Dechert, MS - adechert@conformalmedical.com
NCT05147792
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• Male or non-pregnant female aged ≥18 years
• Documented non-valvular AF (paroxysmal, persistent, or permanent)
• High risk of stroke or systemic embolism, defined as CHA2DS2-VASc score of ≥ 3
• Has an appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation
• Deemed by the site investigator to be suitable for short term oral anticoagulation therapy but deemed less favorable for long-term oral anticoagulation therapy.
• Deemed appropriate for LAA closure by the site investigator and a clinician not a part of the procedural team using a shared decision-making process in accordance with standard of care
• Able to comply with the protocol-specified medication regimen and follow-up evaluations
• The subject (or legally authorized representative, where allowed) has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate institutional review board (IRB)/Regional Ethics Board (REB)/Ethics Committee (EC).
Exclusion Criteria:
• Pregnant or nursing patients and those who plan pregnancy in the period up to one year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.
• Anatomic conditions that would prevent performance of an LAA occlusion procedure (e.g., atrial septal defect (ASD) requiring closure, high-risk patent foramen ovale (PFO) requiring closure, a highly mobile inter-atrial septal aneurysm precluding a safe TSP, presence of a PFO/ASD closure device, history of surgical ASD repair or history of surgical LAAO closure)
• Atrial fibrillation that is defined by a single occurrence or that is transient or reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
• A medical condition (other than atrial fibrillation) that mandates long-term oral anticoagulation (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or prosthetic mechanical heart valve)
• History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated
• Documented active systemic infection
• Symptomatic carotid artery disease (defined as \>50% stenosis with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is \<50% stenosis noted at the site of prior treatment
• Recent (within 30 days of index procedure) or planned (within 60 days post-procedure) cardiac or major non-cardiac interventional or surgical procedure
• Recent (within 30 days of index procedure) stroke or transient ischemic attack
• Recent (within 30 days of index procedure) myocardial infarction
• Vascular access precluding delivery of implant with catheter-based system
• Severe heart failure (New York Heart Association Class IV)
• Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any prosthetic mechanical valve implant
• Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation)
• Platelet count \<75,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<3,000 cells/mm3
• Known allergy, hypersensitivity or contraindication to aspirin, heparin, or device materials (e.g., nickel, titanium) that would preclude any P2Y12 inhibitor therapy, or the patient has contrast sensitivity that cannot be adequately pre-medicated
• Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial
• Unable to undergo general anesthesia
• Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol or protocol-specified medication regimen, confound the data interpretation, or is associated with a life expectancy of less than 5 years
• A condition which precludes adequate transesophageal echocardiographic assessment Echo exclusion criteria:
• Left atrial appendage anatomy which cannot accommodate a commercially available control device or the CLAAS Implant per manufacturer IFU (e.g., the anatomy and sizing must be appropriate for both the investigational (CLAAS) and a commercially available device in order to be enrolled in the trial)
• Intracardiac thrombus or dense spontaneous echo contrast consistent with thrombus, as visualized by TEE prior to implant
• Left ventricular ejection fraction (LVEF) \<30%
• Moderate or large pericardial effusion \>10 mm or symptomatic pericardial effusion, signs or symptoms of acute or chronic pericarditis, or evidence of tamponade physiology
• Atrial septal defect that warrants closure
• High risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (excursion \>15 mm or length \> 15 mm) or large shunt (early \[within 3 beats\] and/or substantial passage of bubbles, e.g., \>20)
• Moderate or severe mitral valve stenosis (mitral valve area \<1.5 cm2)
• Complex atheroma with mobile plaque of the descending aorta and/or aortic arch
• Evidence of cardiac tumor
DEVICE: CLAAS, DEVICE: WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder
Atrial Fibrillation, Stroke
I'm interested
Share via email
Show 70 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| AKFA Medline Olmazor, Tashkent | |
| Abrazo Arizona Heart Hospital Phoenix, Arizona | |
| AdventHealth Orlando Orlando, Florida | Chantie Garvey - (chantie.garvey@adventhealth.com) |
| AdventHealth Tampa Tampa, Florida | Daniel Robledo - (daniel.robledo@adventhealth.com) |
| Albany Medical Center / Capital Cardiology Associates Albany, New York | Mara Zink - (mzink@capitalcardiology.com) |
| Ascension St. Vincent - Carmel, IN Indianapolis, Indiana | |
| Ascension St. Vincent's Jacksonville Jacksonville, Florida | |
| Baptist Hospital of Miami Miami, Florida | Maria Ardid - (mariaar@baptisthealth.net) |
| Baystate Medical Center Springfield, Massachusetts | Christine Callahan - (Christine.Callahan@baystatehealth.org) |
| CHI Health / CommonSpirit Research Institute Omaha, Nebraska | Maddie Esch - (maddie.esch@commonspirit.org) |
| CHRISTUS Health Tyler, Texas | Jamie-Crystal Wylie - (jamiecrystal.wylie@christushealth.org) |
| Carilion Clinic Roanoke, Virginia | Brittny O'Toole - (bmotoole@carilionclinic.org) |
| Catholic Medical Center Manchester, New Hampshire | |
| Centracare Heart and Vascular Center Saint Cloud, Minnesota | Audrey Hillebrand-Raap - (Audrey.Hillenbrand-Raap@centracare.com) |
| Chapidze Heart Disease Center Tbilisi, | Teona Gamezardashvili - (t.gamezardashvili@clinicalaccelerator.com) Beka Khakhutashvili - (b.khakhutashvili@clinicalaccelerator.com) |
| Chippenham Hospital Richmond, Virginia | Ariana Dickens - (Ariana.Dickens@hcahealthcare.com) |
| Community Memorial Hospital Ventura Ventura, California | Melissa Grant - (melissa@siteresearchmgmt.com) |
| Cooper University - Heart House Haddon Heights, New Jersey | Kaitlyn Downey - (KDowney@hearthousenj.com) |
| Corewell Health Grand Rapids, Michigan | |
| Emory University Atlanta, Georgia | Teressa Burns - (teressa.burns@emory.edu) |
| Erlanger Health System Chattanooga, Tennessee | Kumari Kasa - (Parvathikumari.Kasa@erlanger.org) |
| Grandview Medical Center Birmingham, Alabama | Kristy Raco - (kristy.raco@grandviewhealth.com) |
| Hackensack University Medical Center Hackensack, New Jersey | Tarah Martelly - (tarah.martelly@hmhn.org) |
| Henry Ford Providence Southfield Hospital Southfield, Michigan | |
| Henry Ford St. John Hospital Detroit, Michigan | Renee Bess - (rbess1@hfhs.org) |
| HonorHealth Scottsdale, Arizona | Kiersten Rundio - (krundio@honorhealth.com) |
| Houston Methodist Houston, Texas | Chinwe Ngumezi - (ccngumezi@houstonmethodist.org) |
| Huntington Hospital Huntington, New York | Samia Solh - (Samia.Solh@huntingtonhealth.org) |
| Hôpital Privé Jacques Cartier Massy, | Séverine Roger - (s.roger@icps.com.fr) |
| Israeli-Georgian Medical Research Clinic Helsicore Tbilisi, | Natalia Cornea - (n.cornea@clinicalaccelerator.com) Teona Gamazerdashvili - (t.gamezardashvili@clinicalaccelerator.com) |
| Kansas City Cardiac Arrhythmia Research, LLC Overland Park, Missouri | Rachael Koeppe - (rachael.koeppe@hcahealthcare.com) |
| Lahey Hospital & Medical Centeer Burlington, Massachusetts | Jean Byrne - (jean.byrne@lahey.org) |
| Lankenau Heart Institute Wynnewood, Pennsylvania | Rachael Cohen - (cohenrac@mlhs.org) |
| Largo Medical Center Upper Marlboro, Maryland | Holly Lynn Grospitch - (HollyLynn.Grospitch@hcahealthcare.com) |
| Legacy Emanuel Hospital and Health Portland, Oregon | Karla Kummer - (kkummer@lhs.org) |
| Lifespan Health System Providence, Rhode Island | |
| M Health Fairview St. John's Hospital Maplewood, Minnesota | Beth Jorgenson - (beth.jorgenson@fairview.org) |
| MedStar Union Memorial Hospital Baltimore, Maryland | Keith Moyer - (Keith.T.Moyer@medstar.net) |
| Medstar Washington Hospital Center Washington D.C., District of Columbia | |
| Memorial Hermann Memorial City Medical Center Houston, Texas | Maddie Peek - (maddie@whactc.com) |
| Midwest Cardiovascular Institute Naperville, Illinois | Sherri McCoy - (Sherri.McCoy@cardio.com) |
| Mission Hospital Asheville, North Carolina | Christina Riggsbee - (christina.riggsbee@hcahealthcare.com) |
| Mount Sinai Hospital New York, New York | Joshua Wiener - (joshua.wiener@mountsinai.org) |
| North Mississippi Medical Center Tupelo, Mississippi | Kristin Eads - (KEads@nmhs.net) |
| Northside Hospital, Inc Atlanta, Georgia | Katie Moore - (katie.moore@northside.com) |
| Ohio Health Research Institute Columbus, Ohio | |
| Pacific Heart Institute Santa Monica, California | Stacy Chang - (research@pacificheart.com) |
| Piedmont Health Institute Atlanta, Georgia | Caryn Bernstein - (caryn.bernstein@piedmont.org) |
| Pima Heart & Vascular Tucson, Arizona | |
| Promedica Toledo Hospital Toledo, Ohio | Sonya Inderrieden - (Sonya.Inderrieden@ProMedica.org) |
| Republican Specialized Center for Surgery named after V. Vakhidov Chilanzar, Tashkent | |
| Saint Luke's Hospital of Kansas City Kansas City, Missouri | Cheryl Rutherford - (cjrutherford@saint-lukes.org) |
| Sarasota Memorial Health Care System Sarasota, Florida | Kristen Sangmaster - (kristen-sangmaster@smh.com) |
| Senatra Norfolk Norfolk, Virginia | Linette Klevan - (LRKLEVAN@sentara.com) |
| St. Bernard's Medical Center Jonesboro, Arkansas | Kayla Rubino - (krubino@dnairresearch.com) |
| Tbilisi Heart Center Tbilisi, | Ketevan Gabunia, MD - (kgabunia@tbhc.ge) |
| Tbilisi Heart and Vascular Clinic Tbilisi, | Natalia Cornea - (n.cornea@clinicalaccelerator.com) Teona Gamezardashvili - (t.gamezardashvili@clinicalaccelerator.com) |
| Tennova Healthcare - Turkey Creek Medical Center Knoxville, Tennessee | Juliana Bailey - (juliana.bailey@tennova.com) |
| Terrebone - Cardiovascular Institute of the South Houma, Louisiana | Jennifer Aucoin - (jennifer.aucoin@cardio.com) |
| TriHealth Cincinnati, Ohio | Marta McClellan - (Marta_McClellan@trihealth.com) |
| Trident Medical Center Charleston, South Carolina | Molly Harper - (Molly.Harper@hcahealthcare.com) |
| UPMC Harrisburg Mechanicsburg, Pennsylvania | Matthew Rutt - (ruttmd4@upmc.edu) |
| USF - Tampa General Hospital Tampa, Florida | Jacky He - (jackyhe@usf.edu) |
| University of Buffalo / Kaleida Health Buffalo, New York | Cassandra Davern - (cadavern@buffalo.edu) |
| University of Iowa Iowa City, Iowa | Trisha Elliott - (trisha-elliott@uiowa.edu) |
| University of Kansas Medical Center Kansas City, Kansas | Grace Millington - (gmillington@kumc.edu) |
| Vanderbilt University Medical Center Nashville, Tennessee | Amanda Caroll - (Amanda.carroll@vumc.org) |
| Virginia Commonwealth University Richmond, Virginia | Esoterica Berry - (Esoterica.Berry@vcuhealth.org) |
| Wellstar Kennestone Hospital Marietta, Georgia | Jennifer Cuvo - (Jennifer.Cuvo@wellstar.org) |
| West Virginia University Morgantown, West Virginia | Marvin Hudson - (marvin.hudson1@wvumedicine.org) |
The Effects of IL-1 Blockade on Inotrope Sensitivity in Patients With Heart Failure (AID-HEART) (AID-HEART)
Benjamin VanTassell - bvantassell@vcu.edu
NCT06062966
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Primary diagnosis for the clinic visit is stage D heart failure being on chronic stable dose of inotrope therapy (dobutamine or milrinone for the previous 28 days)
* Prior documentation of impaired left ventricular systolic function (ejection fraction \<50%) at most recent assessment by any imaging modality (within 12 months)
* Stable dose of inotrope treatment without a recent hospitalization within the previous month
* Age ≥21 years and willing/able to provide written informed consent
* The patient is willing and able to comply with the protocol (i.e. self administration of the treatment, and exercise protocol).
* Screening plasma C-reactive protein levels \>2 mg/L
Exclusion Criteria:
* Concomitant clinically significant comorbidities including (but not limited to) acute coronary syndromes, uncontrolled hypertension or orthostatic hypotension, tachy- or brady-arrhythmias, acute or chronic pulmonary disease or neuromuscular disorders affecting respiration that would interfere with the execution, interpretation, or completion of the study
* Recent (previous 3 months) or planned resynchronization therapy (CRT), or valve surgeries
* Previous or planned implantation of left ventricular assist devices or heart transplant within the next 3 months
* Recent (\<14 days) use of immunosuppressive or anti-inflammatory drugs (including oral corticosteroids at a dose of prednisone equivalent of 0.5 mg/kg/day but not including inhaled or low dose oral corticosteroids or non-steroidal anti-inflammatory drugs)
* Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus)
* Active infection (of any type), including chronic/recurrent infectious disease (including HBV, HCV, and HIV/AIDS) - but excluding HCV+ with undetectable plasma RNA
* Prior (within the past 5 years) or current malignancy on targeted treatment - excluding carcinoma in situ \[any location\] or localized non-melanoma skin cancer
* Stage V kidney disease or on renal-replacement therapy
* Neutropenia (\<1,500/mm3 or \<1,000/mm3 in African-American patients)
* Pregnancy or breastfeeding
* Angina, hypertension, arrhythmias, electrocardiograph (ECG) changes, or other non-cardiac limitations that limit 6MWD obtained during the baseline testing
* Hypersensitivity to anakinra or to E. coli derived products DRUG: Anakinra
Heart Failure
Inotrope sensitivity, IL-1 Blockade, Subcutaneous (SC), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV, 6 Minute Walk Test (6MWT)
I'm interested
Share via email
Show 1 location
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Azita Talasazah - (talasazah@vcu.edu) Benjamin Van Tassell - (bvantassell@vcu.edu) |
ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack (ARTEMIS)
Novo Nordisk - clinicaltrials@novonordisk.com
NCT06118281
Show full eligibility criteria
Hide eligibility criteria
Key inclusion:
* Age 18 years or above at the time of signing the informed consent.
* Hospitalisation for acute myocardial infarction with evidence of type 1 myocardial infarction (MI) by invasive angiography performed at site with percutaneous coronary intervention (PCI) capabilities.
* ST-segment elevation myocardial infarction (STEMI) with all the following: a) Relevant onset of symptoms suggestive of cardiac ischaemia within 12 hours before hospitalisation, at the investigator's discretion.
b) Electrocardiogram (ECG)-changes (in the absence of left ventricular hypertrophy or left bundle branch block): ST-segment elevation at the J point in at least two contiguous leads greater than or equal 0.25 (millivolt) mV in men less than 40 years, greater than or equal 0.2 mV in men greater than or equal 40 years, or greater than or equal 0.15 mV in women in leads V2-V3; and/or greater than or equal 0.1 mV in all other leads.
OR
* Non-ST-segment myocardial infarction with all the following: a) Relevant onset of symptoms suggestive of cardiac ischaemia within 24 hours before hospitalisation, at the investigator's discretion. b) Rise and/or fall in car-diac troponin I or T with at least one value above the 99th percentile upper reference limit.
* Possibility for both randomisation and administration of the loading dose of study intervention as early as possible after invasive procedure, and latest within 36 hours of hospitalisation (time 0) for STEMI, and latest within 72 hours of hospitalisation (time 0) for NSTEMI.
* Presence of at least one of the following criteria confirmed based on the participant's medical records and/or medical history interview: a) Any prior MI. b) Prior coronary revascularisation. c) Diabetes mellitus treated with ongoing glucose-lowering agent(s). d)Known chronic kidney disease (CKD) (estimated glomerular filtration rate (eGFR) greater than or equal to 15 and less than 60 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2). e) Prior ischaemic stroke. f) Known carotid disease or peripheral artery disease in the lower extremities. g) Multivessel coronary artery disease (current/prior). h) For STEMI patients only: anterior MI at index acute myocardial infarction (AMI)
Key exclusion:
* Use of fibrinolytic therapy for treatment of the current AMI.
* Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV.
* Ongoing haemodynamic instability defined as any of the following: a) Killip Class III or IV. b) Sustained and/or symptomatic hypotension (systolic blood pressure less than 90 millimeters of mercury (mmHg)).
* Severe kidney impairment defined as any of the following: a) eGFR less than 15 mililitre per minute per 1.73 m\^2. b) Chronic haemodialysis or peritoneal dialysis.
* Known alanine aminotransferase (ALT) greater than 8 x upper limit of normal (reference range) (ULN).
* Severe hepatic disease defined as at least one of the following: a) Previously known or current hepatic encephalopathy (clinical evaluation). b) Previously known or current ascites (clinical eval-uation). c) Jaundice (clinical evaluation). d) Previous oesophageal/gastric variceal bleeding. c) Known hepatic cirrhosis.
* Major cardiac surgical (including but not restricted to coronary artery bypass graft surgery (CABG)), non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days or any major surgical procedure planned at the time of randomisation or as treatment for the current AMI (CABG). Deferred (staged)percutaneous coronary intervention for a non-culprit vessel identified during the current AMI is allowed.
* Clinical evidence of, or suspicion of, active infection at the discretion of the investigator.
* Known (acute or chronic) hepatitis B or hepatitis C.
* History or evidence of untreated latent tuberculosis (TB) such as (but not limited to): a) History of a positive TB test or chest X-ray compatible with latent TB; and TB treatment initiated less than 28 days prior to randomisation. b) Participants with TB risk factors but unwilling to undergo TB treatment if confirmed positive for latent TB based on central laboratory test at baseline (visit 2).
DRUG: Ziltivekimab, DRUG: Placebo
Cardiovascular Risk, Acute Myocardial Infarction (AMI)
I'm interested
Share via email
Show 873 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| "AHEPA" University General Hospital of Thessaloniki Thessaloniki, | |
| "AHEPA" University General Hospital of Thessaloniki Thessaloniki, | |
| "Hygeia" General Hospital of Athens Athens, | |
| "MHAT - Pazardzhik" Pazardzhik, | |
| "Sotiria" Thoracic Diseases Hospital of Athens Athens, | |
| "UMHAT "Aleksandrovska" EAD, Cardiology clinic Sofia, | |
| "UMHAT "Sveta Anna" Sofia" AD, Clinic of Cardiology Sofia, | |
| "UMHAT-Burgas" Burgas, | |
| "UMHATEM N.I. Pirogov" EAD Sofia, | |
| 'G. Gennimatas' General Hospital of Athens Athens, | |
| 'G. Gennimatas' General Hospital of Athens Athens, | |
| 'MHAT Hadzhi Dimitar' OOD Sliven, | |
| 'MHAT Sveta Karidad' EAD Plovdiv, | |
| 1 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ Lublin, | |
| 10 Wojskowy Szpital Kliniczny z Polikliniką - Samodzielny Publiczny Zakład Opieki Zdrowotnej w Bydgoszczy Bydgoszcz, | |
| 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu Wroclaw, Lower Silesian Voivodeship | |
| A.O.U Città della Salute e della Scienza di Torino Torino, | |
| A.O.U Città della Salute e della Scienza di Torino Torino, | |
| A.O.U. Ferrara, Sant'Anna Cona (Ferrara), Fe | |
| AORN "Sant'Anna e San Sebastiano" Caserta, Ce | |
| AOU Maggiore della Carità di Novara - Dipartimento Toraco-Cardio-Vascolare - SCDU Cardiologia Novara, | |
| AOUI Verona Verona, | |
| ASSOCIAÇÃO LAR SÃO FRANCISCO DE ASSIS NA PROVIDÊNCIA DE DEUS - Hospital Regional de Presidente Prudente Presidente Prudente, São Paulo | |
| AUSL Romagna - Distretto Rimini - Ospedale Infermi Rimini, | |
| Aakash Healthcare Super Speciality Hospital New Delhi, | |
| Aalborg Universitetshospital Kardiologisk Afdeling Aalborg, | |
| Aalborg Universitetshospital Kardiologisk Afdeling Aalborg, | |
| Aarhus Universitetshospital, Hjertesygdomme Aarhus N, | |
| Abbott Northwestern Hospital Minneapolis, Minnesota | |
| Acibadem City Clinic UMHAT EOOD Sofia, | |
| Acibadem City Clinic UMHAT Tokuda EAD Sofia, | |
| Advanced Cardiovascular, LLC Alexander City, Alabama | |
| Advanced Heart & Vein Center Thornton, Colorado | |
| Advanced Heart Care LLC Bridgewater, New Jersey | |
| Adventist Healthcare Shady Grove Medical Center Rockville, Maryland | |
| Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Kardiyoloji Afyonkarahisar, | |
| Ajou University Hospital Gyeonggi-do, | |
| Akdeniz University Medical Faculty Antalya, | |
| Alexandra General Hospital, Therapeutic Clinic Athens, | |
| All India Institute of Medical Sciences (AIIMS) New Delhi, National Capital Territory of Delhi | |
| All India Institute of Medical Sciences (AIIMS) New Delhi, National Capital Territory of Delhi | |
| All India Institute of Medical Sciences (AIIMS), Bhubaneswar Bhubaneswar, Odisha | |
| All India Institute of Medical Sciences (AIIMS), Nagpur Nagpur, Maharashtra | |
| American Heart of Poland S.A. Zgierz, | |
| American Heart of Poland S.A. Zgierz, | |
| American Heart of Poland S.A. Zgierz, | |
| American Heart of Poland S.A. Zgierz, | |
| American Heart of Poland S.A. Zgierz, | |
| American Heart of Poland S.A. Zgierz, | |
| American Heart of Poland S.A. Zgierz, | |
| American Heart of Poland S.A. Zgierz, | |
| Amper Kliniken AG - Helios Amper-Klinikum Dachau - Kardiologie Dachau, | |
| Amphia Ziekenhuis Breda, | |
| AnMed Health Clinical Research Anderson, South Carolina | |
| Ankara Sehir Hastanesi Cardiology Ankara, | |
| Ankara University Medical Faculty Ankara, | |
| Antalya İl Sağlık Müdürlüğü Antalya EAH Muratpasa/ Antalya, | |
| Ap-Hp-Hopital Bichat-Claude Bernard-1 Paris, | |
| Ap-Hp-Hopital Europeen Georges Pompidou Paris, | |
| Aphp-Hopital La Pitie Salpetriere-1 Paris, | |
| Apollo Multispeciality Hospital, Kolkata Kolkata, West Bengal | |
| Arcispedale S Maria Nuova Azienda ULSS-IRCCS Reggio Emilia, | |
| Arkansas Cardiology Clinic Little Rock, Arkansas | |
| Arneja Heart & Multispeciality Hospital Nagpur, Maharashtra | |
| Asahi General Hospital＿Cardiology Chiba, | |
| Asan Medical Center Seoul, | |
| Ascension Sacred Heart Pensacola, Florida | |
| Ascension St. Mary's Research Institute - Michigan Southfield, Michigan | |
| Asklepieion General Hospital Athens/Voula, | |
| Asklepios Klinik Langen - Medizinische Klinik I Langen, | |
| Assistance Publique Hopitaux de Marseille-Hopital de La Timone-1 Marseille, | |
| Associação Lar São Francisco de Assis na Providência de Deus - Bragança Paulista Bragança Paulista, São Paulo | |
| Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital New Delhi, National Capital Territory of Delhi | |
| Atlanta VAMC Decatur, Georgia | |
| AtlantiCare Regional Medi Cnt Pomona, New Jersey | |
| Augusta University Augusta, Georgia | |
| Augusta University Augusta, Georgia | |
| Aultman Hospital Canton, Ohio | |
| Aurora St. Luke's Medi Ctr Milwaukee, Wisconsin | |
| Austin Health Heidelberg, Victoria | |
| Austin Heart Austin, Texas | |
| Azienda Ospedaliera Santa Maria Degli Angeli Pordenone, PN | |
| Azienda Ospedaliera Universitaria Careggi Florence, | |
| Azienda Ospedaliera Universitaria Federico II di Napoli Napoli, | |
| Azienda Ospedaliera di Parma Parma, | |
| Azienda Ospedaliera di Parma Parma, | |
| Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli Napoli, | |
| Azienda Ospedaliero - Universitaria Sant'Andrea Rome, | |
| Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara Novara, | |
| Azienda Ospedaliero-Universitaria Renato Dulbecco Catanzaro, Cz | |
| Azienda Ospedaliero-Universitaria SS Antonio e Biagio e Cesare Arrigo Alessandria, | |
| Azienda Sanitaria Friuli Occidentale - Azienda Ospedaliera Santa Maria Degli Angeli - SC Cardiologia Pordenone Pordenone, PN | |
| Azienda Sanitaria Ospedaliera Ordine Mauriziano SC Cardiologia Torino, To | |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Bergamo, Lombardy | |
| Azienda Unità Sanitaria Locale Di Piacenza - Cardiologia Piacenza, | |
| B M Birla Heart Research Centre Kolkata, West Bengal | |
| B M Birla Heart Research Centre Kolkata, West Bengal | |
| BG Klinikum Unfallkrankenhaus Berlin GmbH - Klinik für Kardiologie Berlin, | |
| Baptist Clin Res Institute Memphis, Tennessee | |
| Baptist Heart Specialists Jacksonville, Florida | |
| Baptist Hospital Cardiology Pensacola, Florida | |
| Barts Heart Centre London, | |
| Barts Heart Centre London, | |
| Barwon Health (The Geelong Hospital) Geelong, Victoria | |
| Batra Hospital and Medical Research Center New Delhi, National Capital Territory of Delhi | |
| Baylor Scott & White Res Inst Plano, Texas | |
| Beijing Anzhen Hospital, Capital Medical University Beijing, Beijing Municipality | |
| Bellvitge Universitary Hospital Badalona, | |
| Birmingham VA Medical Center Birmingham, Alabama | |
| Blackpool Victoria Hospital Blackpool, | |
| Bon Secours St. Mary's Hospital of Richmond, LLC Richmond, Virginia | |
| Bravis Ziekenhuis Roosendaal, | |
| Bremer Institut für Herz- und Kreislaufforschung (BIHKF) Bremen, | |
| Bridgeport Hospital Bridgeport, Connecticut | |
| Brigham & Women's Hospital Boston, Massachusetts | |
| Bursa Yüksek İhtisas Eğitim ve Araştırma Merkezi-Kardiyoloji Bursa, | |
| Bursa Şehir Hastanesi- Kardiyoloji Bursa, | |
| CHU de Quebec-Universite-Laval,HDQ Québec, | |
| CHUM Centre de Recherch Hotel-Dieu Montreal, Quebec | |
| CHUM Centre de Recherch Hotel-Dieu Montreal, Quebec | |
| CIP Centro Integrado de Pesquisas do Hospital de Base São José do Rio Preto, São Paulo | |
| CIP Centro Integrado de Pesquisas do Hospital de Base São José do Rio Preto, São Paulo | |
| CISSS de Lanaudiere - Centre hospitalier De Lanaudiere Saint-Charles-Borromée, Quebec | |
| CISSSL Hôsp Pierre-Le Gardeur Terrebonne, Quebec | |
| CIUSS Hopit de Chicoutimi Chicoutimi, Quebec | |
| CV Research of Knoxville Powell, Tennessee | |
| Cairns Base Hospital Cairns, Queensland | |
| Cangzhou Central Hospital Cangzhou Shi, Hebei | |
| Canisius-Wilhelmina ziekenhuis Nijmegen, | |
| Cardio. Consult. of S. GA Thomasville, Georgia | |
| Cardiolg Assoc Rsch LLC_Tupelo Tupelo, Mississippi | |
| Cardiology Associates of Fairfield County Stamford, Connecticut | |
| Cardiology Associates_Asheville Asheville, North Carolina | |
| Cardiología Hospital J. M. Ramos Mejia Buenos Aires, | |
| Cardiovascular Associates of the Delaware Valley Vineland, New Jersey | |
| Catharina Ziekenhuis Eindhoven Eindhoven, | |
| Cellitinnen-Krankenhaus St. Vinzenz Köln - Kardiologie Cologne, | |
| Central Arkansas Veteran's Healthcare System Little Rock, Arkansas | |
| Central India Cardiology Hospital and Research Institute Nagpur, Maharashtra | |
| Centre Hospitalier Regional Universitaire de Tours-Hopital Trousseau Chambray-lès-Tours, | |
| Centre Hospitalier Saint Joseph Saint Luc Lyon, | |
| Centre Hospitalier Sud Francilien Corbeil-Essonnes, | |
| Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-1 Grenoble, | |
| Centre Hospitalier Universitaire de Besancon-Hopital Jean Minjoz Besançon, | |
| Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-1 Pessac, | |
| Centre Hospitalier Universitaire de Caen Normandie- Cote de Nacre-1 Caen, | |
| Centre Hospitalier Universitaire de Lille-Institut Coeur Poumon Lille, | |
| Centre Hospitalier Universitaire de Nice-Hopital Pasteur Nice, | |
| Centre Hospitalier Universitaire de Poitiers Poitiers, | |
| Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1 Toulouse, | |
| Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1 Toulouse, | |
| Centre hosp affilié univ rég Trois-Rivières, Quebec | |
| Centro Médico Nacional Siglo XXI Mexico City, | |
| Centro Privado de Cardiología San Miguel de Tucuimán, Tucumán Province | |
| Centro de Estudios Clinicos de Querétaro S.C. Querétaro, | |
| Centro de Estudios Clinicos de Querétaro S.C. Querétaro, | |
| Centro de Imagen y Tecnologia en Intervención Cardiovascular México, La Magdalena Contreras | |
| Centro de Investigación C.I.C.E 9 de Julio - Sanatorio 9 de Julio San Miguel de Tucumán, Tucumán Province | |
| Centro de Pesquisa Clínica do Hospital de Clínicas da Universidade Federal de Uberlândia Uberlândia, Minas Gerais | |
| Centro de atención e investigación cardiovascular del Potosí San Luis Potosí City, | |
| Cerrahpaşa Kardiyoloji Enstitüsü Istanbul, | |
| Chambersburg Hospital Chambersburg, Pennsylvania | |
| Charité - Campus Benjamin Franklin - Klinik für Kardiologie Berlin, | |
| Chattanooga Heart Institute Chattanooga, Tennessee | |
| Chattanooga Heart Institute Chattanooga, Tennessee | |
| China-Japan Friendship Hospital Beijing, | |
| China-Japan Friendship Hospital Beijing, | |
| China-Japan Union Hospital of Jilin University Changchun, Jilin | |
| China-Japan Union Hospital of Jilin University-Cardiology Changchun, Jilin | |
| Chinese Academy of Medical Sciences Fuwai Hospital Beijing, Beijing Municipality | |
| Chippenham Medical Center Richmond, Virginia | |
| Chonnam National University Hospital Gwangju, | |
| Chopda Medicare and Research Centre Pvt. Ltd. Nashik, Maharashtra | |
| Christiana Care Health Services, Inc. Newark, Delaware | |
| Christus Heart and Vascular Institute Tyler, Texas | |
| Chru de Nancy - Hopital Brabois Vandœuvre-lès-Nancy, | |
| Chungbuk National University Hospital Cheongju-si, North Chungcheong | |
| Chungnam National University Hospital Daejeon, | |
| Chungnam National University Sejong Hospital Sejong-si, | |
| Cleveland Clinic_Cleveland Cleveland, Ohio | |
| Clínica Privada Velez Sarsfield Córdoba, | |
| Clínica Privada Velez Sarsfield Córdoba, | |
| Complejo Hospitalario Universitario A Coruna A Coruña, | |
| Concord Repatriation General Hospital - Cardiology Department Concord, New South Wales | |
| Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk, | |
| Corewell Health Grand Rapids, Michigan | |
| Dallas VA Medical Center Dallas, Texas | |
| Danbury Hospital - Cardiology Department Danbury, Connecticut | |
| Dartmouth-Hitchcock Med Ctr Lebanon, New Hampshire | |
| Dayanand Medical College & Hospital Ludhiana, Punjab | |
| Deenanath Mangeshkar Hospital & Research Centre Pune, | |
| Deenanath Mangeshkar Hospital & Research Centre Pune, | |
| Denver Health Medical Center Denver, Colorado | |
| Derriford Hospital Plymouth, | |
| Deutsches Herzzentrum TU München - Klinik für Herz- und Kreislauferkrankungen München, | |
| Dolnoslaski Szpital Specjalistyczny Im. T.Marciniaka-Centrum Medycyny Ratunkowej Wroclaw, | |
| Dr. Ram Manohar Lohia Institute of Medical Sciences Lucknow, Uttar Pradesh | |
| Dr. Ram Manohar Lohia Institute of Medical Sciences Lucknow, Uttar Pradesh | |
| Dr. Siyami Ersek Gogus Kalp ve Damar Cerrahisi EAH Istanbul, | |
| Duke University Medical Center Durham, North Carolina | |
| ESIC Medical College and Hospital, Hyderabad Hyderabad, Telangana | |
| Eastern Shore Rsrch Inst, LLC Fairhope, Alabama | |
| Ehime Prefectural Central Hosp Ehime, | |
| Elisabeth-TweeSteden Ziekenhuis Tilburg, | |
| Emory University Hospital Atlanta, Georgia | |
| Endeavor Health Glenbook Hosp Evanston, Illinois | |
| Ente Ecclesiastico Ospedale Generale Regionale Miulli - Cardiologia e UTIC Acquaviva delle Fonti, | |
| Erciyes University Cardiology Kayseri, | |
| Eskisehir Osmangazi University Sağlık Uygulama ve Arastirma Eskişehir, Odunpazari | |
| Eskisehir Sehir Hospital Odunpazarı /Eskişehir, | |
| Essentia Health Duluth, Minnesota | |
| Evangelismos Hospital Athens, | |
| Ewha Womans University Seoul Hospital Seoul, | |
| FN u Sv. Anny Brno, | |
| Fairview Health Services Maplewood, Minnesota | |
| Fairview Health Services Maplewood, Minnesota | |
| Fakultni nemocnice Brno Brno, | |
| Fakultni nemocnice Kralovske Vinohrady Prague, | |
| Fakultni nemocnice Olomouc Olomouc, | |
| Fakultni nemocnice Plzen - Lochotin Plzen - Lochotín, | |
| Flinders Medical Centre Bedford Park, | |
| Fondazione IRCCS Policlinico San Matteo Pavia, | |
| Fondazione IRCCS San Gerardo dei Tintori Monza, | |
| Fondazione Policlinico Universitario Agostino Gemelli IRCS Roma, | |
| Fondazione Policlinico Universitario Agostino Gemelli Irccs Roma, | |
| Fortis Escorts Heart Institute, New Delhi New Delhi, National Capital Territory of Delhi | |
| Fortis Hospital, Mohali Mohali, Punjab | |
| Frankston Hospital Frankston, Victoria | |
| Freeman Hospital, Newcastle Newcastle upon Tyne, | |
| Fujita Health University Hospital_Cardiology Aichi, | |
| Fukuoka University Hospital_Cardiology Fukuoka-shi, Fukuoka, | |
| Fundacion Favaloro CABA, Buenos Aires, Argentina | |
| Fundación Nuestra Señora del Rosario - Estudios Clínicos los Arroyos San Nicolás de los Arroyos, Buenos Aires | |
| G B Pant Institute of Postgraduate Medical Education and Research New Delhi, National Capital Territory of Delhi | |
| G. Kuppuswamy Naidu Memorial Hospital Coimbatore, Tamil Nadu | |
| G. Kuppuswamy Naidu Memorial Hospital Coimbatore, Tamil Nadu | |
| G.H. of Athens "Evaggelismos" Athens, | |
| Gachon University Gil Medical Center Incheon, | |
| Ganesh Shankar Vidyarthe Memorial (GSVM) Medical College Kanpur, Uttar Pradesh | |
| Gangdong Kyung Hee University Hospital Seoul, | |
| Geisinger Medical Center Danville, Pennsylvania | |
| Gen Hospital of Thessaloniki G.Papanikolaou,Cardiology Dpt Thessaloniki, | |
| General Hospital Of Eleusina Thriasio Eleusina, | |
| General Hospital of Athens "Elpis" Ampelokipoi/Athens, | |
| General Hospital of Athens "Laiko" Goudi, Athens, | |
| General Hospital of Chios "Skilitsio" Chios, | |
| General Hospital of Imathia Monada Veria Véroia, | |
| General Hospital of Imathia Monada Veria Véroia, | |
| General Hospital of Patras Agios Andreas Pátrai, | |
| General Hospital of Thessaloniki PAPAGEORGIOU Nea Efkarpia, Thessaloniki | |
| General Hospital of Tianjin Medical University-Endocrinology Tianjin, Tianjin Municipality | |
| Genesis Health Care System Zanesville, Ohio | |
| Glenfield Hospital Leicester, | |
| Gold Coast University Hosptial Southport, Queensland | |
| Golden Jubilee University National Hospital Glasgow, | |
| Grande Ospedale Metropolitano Niguarda Milan, | |
| Grandview Medical Center Birmingham, Alabama | |
| Grey Nuns Community Hospital Edmonton, Alberta | |
| Groene Hart Ziekenhuis, locatie Bleuland Gouda, | |
| Group Euroclinic - Athens Euroclinic Athens, | |
| Guangdong Provincial People's Hospital Guangzhou, | |
| Guangdong Provincial People's Hospital Guangzhou, | |
| HCA Research Institute McAllen, Texas | |
| Hackensack Meridian Health Hackensack, New Jersey | |
| Hadassah Ein Karam MC - Cardio Department Jerusalem, | |
| Hadassah Mount Scorpus MC - Cardiology department Jerusalem, | |
| Hamilton Health Sciences Corp, Ontario Hamilton, Ontario | |
| Hanaoka Seishu Memorial Hosp._Cardiovascular Medicine Hokkaido, | |
| Hanaoka Seishu Memorial Hospital Hokkaido, | |
| Hanyang University Seoul Hospital Seoul, | |
| Health Sciences North Rsrch Inst Greater Sudbury, Ontario | |
| Heart & Vascular Inst._Titus Mount Pleasant, Texas | |
| Heart Center Rsrch_Hunstville Huntsville, Alabama | |
| Hebei General Hospital Shijiazhuang, Hebei | |
| Helios Klinikum Erfurt GmbH - 3. Med. Klinik - Kardiologie Erfurt, | |
| Henry Dunant Hospital Center Athens, | |
| Heritage Medical Research Clinic Calgary, Alberta | |
| Herlev og Gentofte Hospital Hellerup, Capital Region | |
| Hermosillo Heart Team Hermosillo, Sonora | |
| Hillel Yafe MC - Cardiology Department Hadera, | |
| Hippokration Hospital Athens, | |
| Holy Cross Hospital Fort Lauderdale, Florida | |
| Holy Name Medical Center Teaneck, New Jersey | |
| Honor Health Scottsdale, Arizona | |
| Hopital Sacre-Coeur de Montreal Montreal, Quebec | |
| Hospices Civils de Lyon- Hopital Louis Pradel-1 Bron, | |
| Hospital Agamenon Magalhães Recife, Pernambuco | |
| Hospital Alvaro Cunqueiro de Vigo Vigo, | |
| Hospital Angeles de Culiacan Culiacán, Sinaloa | |
| Hospital Angeles de Xalapa Xalapa, Veracruz | |
| Hospital Angeles de las Lomas México, State of Mexico | |
| Hospital Canselor Tuanku Muhriz UKM Cheras, | |
| Hospital Cardiologica Aguascalientes Aguascalientes, Aguascalientes | |
| Hospital Civil De Guadalajara Fray Antonio Alcalde Guadalajara, Jalisco | |
| Hospital Clinic i Provincial Barcelona, | |
| Hospital Clinico San Carlos Madrid, | |
| Hospital Clinico Universitario de Valencia Valencia, | |
| Hospital Clinico Universitario de Valladolid Valladolid, | |
| Hospital Clinico Virgen de la Victoria Málaga, | |
| Hospital Clinico de Santiago Santiago de Compostela, | |
| Hospital De La Santa Creu I Sant Pau Barcelona, | |
| Hospital Del Mar Barcelona, | |
| Hospital Del Mar Barcelona, | |
| Hospital Dr. Jose Maria Cullen Santa Fe, | |
| Hospital Espanol De Mendoza Godoy Cruz, Mendoza Province | |
| Hospital General Universitario Dr. Balmis Alicante, | |
| Hospital General Universitario Dr. Balmis Alicante, | |
| Hospital General de Mexico (HGM) Cuauhtémoc, México, D.F. | |
| Hospital Germans Trias I Pujol Badalona, | |
| Hospital Germans Trias I Pujol Badalona, | |
| Hospital Gregorio Maranon Madrid, | |
| Hospital Gregorio Maranon Madrid, | |
| Hospital Israelita Albert Einstein Morumbi, São Paulo | |
| Hospital Italiano Buenos Aires, | |
| Hospital Italiano de la Plata La Plata, Buenos Aires | |
| Hospital Juárez de Mexico Ciudad de México, D.F., | |
| Hospital Maternidade e Pronto Socorro Santa Lucia Poços de Caldas, Minas Gerais | |
| Hospital Mãe de Deus - Porto Alegre Porto Alegre/RS, | |
| Hospital Pulau Pinang George Town, | |
| Hospital Queen Elizabeth II Sabak Bernam, | |
| Hospital Raja Perempuan Zainab II Kelantan, | |
| Hospital Raja Permaisuri Bainun Ipoh Ipoh, Perak | |
| Hospital Ramon Y Cajal Madrid, | |
| Hospital Ruy Azeredo Ltda Goiânia, Goiás | |
| Hospital Serdang Kajang, Selangor | |
| Hospital Serdang Kajang, Selangor | |
| Hospital Sultanah Aminah Johor Bahru, Johor | |
| Hospital Sultanah Bahiyah Alor Setar, Kedah, | |
| Hospital São Lucas - PUC/RS Porto Alegre, Rio Grande do Sul | |
| Hospital Tengku Ampuan Afzan Kuantan, Pahang | |
| Hospital Univ. Virgen de la Arrixaca El Palmar, Murcia | |
| Hospital Universitari Joan XXIII Tarragona, | |
| Hospital Universitari Joan XXIII Tarragona, | |
| Hospital Universitario Austral Pilar, | |
| Hospital Universitario Austral Pilar, | |
| Hospital Universitario Dr. Jose Eleuterio Gonzalez Monterrey, Nuevo León | |
| Hospital Universitario La Paz Madrid, | |
| Hospital Universitario Marqués de Valdecilla Santander, | |
| Hospital Universitario Virgen del Rocio Seville, | |
| Hospital Universitario de La Princesa Madrid, M | |
| Hospital Universiti Kebangsaan Malaysia Kuala Lumpur, | |
| Hospital Universiti Sains Malaysia_Kota Bharu, Kelantan Kota Bharu, Kelantan, | |
| Hospital Virgen de la Arrixaca El Palmar, Murcia | |
| Hospital das Clínicas da Universidade Federal do Triangulo Mineiro Uberaba, Minas Gerais | |
| Hospital de Lleida "Arnau de Vilanova" Lleida, | |
| Hospital del Centenario Rosario, Santa Fe, | |
| Hospital do Coração do Brasil Brasília, Federal District | |
| Houston Medical Center Houston, Texas | |
| Houston Medical Center Houston, Texas | |
| Houston Methodist Hospital Houston, Texas | |
| Huashan Hospital Fudan University Shanghai, | |
| Huashan Hospital Fudan University Shanghai, | |
| Hyogo Medical University Hospital_Cardiovascular Medicine Hyōgo, | |
| Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology Himeji-shi, Hyogo, | |
| ICOT Istituto Marco Pasquali - UOC Cardiologia Latina, | |
| II. interni klinika VFN - Kardiologie a angiologie Prague, | |
| IKEM Prague, | |
| IRCCS Policlinico San Donato San Donato Milanese, MI | |
| Ikazia Ziekenhuis Rotterdam, | |
| Illawarra Heart Health Centre Wollongong, New South Wales | |
| Indiana University Health Methodist Hosptial Indianapolis, Indiana | |
| Indraprastha Apollo Hospital, New Delhi New Delhi, National Capital Territory of Delhi | |
| Inha University Hospital Incheon, | |
| Inje University Haeundae Paik Hospital Haeundae-Gu, | |
| Inova Fairfax Medical Campus Falls Church, Virginia | |
| Ins Uni de Cardi et de PNA de Québec, | |
| Inspira Health Mullica Hill, New Jersey | |
| Instituto Cardiovascular Buenos Aires CABA, Buenos Aires | |
| Instituto Dante Pazzanese de Cardiologia São Paulo, | |
| Instituto Nacional de Cardiologia Ignacio Chavez Mexico City, | |
| Instituto Nacional de Ciencias Medicas y Nutricion Tlalpan, Mexico City | |
| Instituto de Cardiología de Corrientes Corrientes, | |
| Instituto de Pesquisa Clinica de Campinas Campinas, São Paulo | |
| Integral Pesquisa e Ensino Votuporanga, | |
| Integral Pesquisa e Ensino Votuporanga, | |
| Interbalkan Medical Center of Thessaloniki Thessaloniki, | |
| Intercard Spolka z ograniczona odpowiedzialnoscia Pińczów, | |
| Intercard Spolka z ograniczona odpowiedzialnoscia Pińczów, | |
| Intercoastal Medical Group Sarasota, Florida | |
| Intercoastal Medical Group Sarasota, Florida | |
| Intermountain Medical Center Murray, Utah | |
| Interventional Cardiology Medical Group West Hills, California | |
| Irmandade Santa Casa de Misericórdia de Passos Passos, Minas Gerais | |
| Irmandade da Santa Casa de Misericordia de Porto Alegre Porto Alegre, | |
| Irmandade da Santa Casa de Misericórdia de Marília Marília, São Paulo | |
| Ishikawa Prefectural Central Hospital_Cardiology Ishikawa, | |
| Ishikiriseiki Hospital_Circulatory Medicine Osaka, | |
| Istanbul University Cerrahpasa Medical Faculty Istanbul, | |
| Jackson Heart Clinic Jackson, Mississippi | |
| Jacobi Medical Center The Bronx, New York | |
| Jadestone Clinical Research, LLC Silver Spring, Maryland | |
| Japanese Red Cross Fukuoka Hospital_Cardiology Fukuoka, | |
| Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) Puducherry, Tamil Nadu | |
| Jawaharlal Nehru Medical College and Hospital Aligarh, Uttar Pradesh | |
| Jawaharlal Nehru Medical College and Hospital Aligarh, Uttar Pradesh | |
| Jeroen Bosch Ziekenhuis 's-Hertogenbosch, | |
| Jersey City Med Center Jersey City, New Jersey | |
| Jinan Central Hospital Affiliated to Shandong University Jinan, Shandong | |
| Jmf Clínica Do Coração Ltda Aracaju, | |
| Juntendo University Shizuoka Hospital Izunokuni-shi, Shizuoka, | |
| Justice K S Hegde Charitable Hospital Mangaluru, Karnataka | |
| KAT General Hospital of Attica Kifissia, | |
| Kagawa Prefectural Central Hospital, Cardiovascular Medicine Takamatsu-shi, Kagawa, | |
| Kaiser Permanente Viewridge Medical Offices San Diego, California | |
| Kanto Rosai Hospital_Cardiology Kanagawa, | |
| Kaplan MC - Cardiac Intensive Care Rehovot, | |
| Kardiologisk Odense & Svendborg Svendborg, | |
| Kartal Kosuyolu Yuksek Ihtisas EAH Istanbul, | |
| Kasturba Medical College and Hospital, Manipal Udupi, Karnataka | |
| Kath. St. Paulus GmbH - St Johannes Hospital Dortmund - Kardiologie Dortmund, | |
| Kayseri City Hospital Kayseri, | |
| Kayseri City Hospital Kayseri, | |
| Keimyung University Dongsan Hospital Daegu, | |
| Kelowna Cardiology Res. Ltd. Kelowna, British Columbia | |
| Kettering General Hospital Kettering, | |
| Kettering Medical Center Kettering, Ohio | |
| King George Hospital Visakhapatnam, Andhra Pradesh | |
| King George's Medical University (KGMU) Lucknow, Uttar Pradesh | |
| King George's Medical University (KGMU) Lucknow, Uttar Pradesh | |
| Kings College Hospital London, | |
| Kings College Hospital London, | |
| Kingston General Hospital Kingston, Ontario | |
| Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie Rzeszów, | |
| Klinikum Friedrichshafen GmbH - Klinik für Kardiologie, Angiologie, Pneumologie und internistische Intensivmedizin Friedrichshafen, | |
| Klinikum Fulda gAG - Med. Klinik I Fulda, | |
| Klinikum Leverkusen gGmbH - Med. Klinik 1 Leverkusen, | |
| Knoxville Heart Group Knoxville, Tennessee | |
| Kocaeli University Medical Faculty İzmit, | |
| Konstantopouleio G.H. of Athens, "Agia Olga" Athens, | |
| Korea University Anam Hospital Seoul, | |
| Korea University Guro Hospital Seoul, | |
| Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z. Ústní Nad Labem, Czechia | |
| Krajská nemocice Liberec, a.s Liberec, | |
| Krajská nemocnice T.Bati a.s. Zlín, | |
| Kyunghee University Medical Center Seoul, | |
| Kyungpook National University Hospital Daegu, | |
| Kütahya Sağlık Bilimleri Üniversitesi Evliya Çelebi Research and Training hospital Kütahya, | |
| Kütahya Şehir Hastanesi Kütahya, | |
| LA BioMed Harbor UCLA Med Cenr Torrance, California | |
| Lakshmi Hospital Palakkad, Kerala | |
| Lalitha Super Specialities Hospital Guntur, Andhra Pradesh | |
| Les Hopitaux de Chartres-Hopital Louis Pasteur Le Coudray, | |
| Lincoln County Hospital Lincoln, | |
| Lindner Center,Christ Hospital Cincinnati, Ohio | |
| Lisie Hospital Kochi, Kerala | |
| Lister Hospital Stevenage, | |
| Liver Ins@ Mthdist DTX Med Cen Dallas, Texas | |
| Liverpool Heart & Chest Hospital Liverpool, | |
| Liverpool Hospital Liverpool, | |
| Liverpool Hospital Liverpool, | |
| Loma Linda University Faculty Medical Clinics Loma Linda, California | |
| London Health Sciences Center Ontario London, Ontario | |
| Louis Stokes Clvlnd VA Med Ctr Cleveland, Ohio | |
| Lyell McEwin Hospital Elizabeth Vale, South Australia | |
| MHAT "Dr. Bratan Shukerov" Smolyan, | |
| MHAT "Dr. Bratan Shukerov" Smolyan, | |
| MHAT "Puls" AD Cardiology Department Blagoevgrad, | |
| MHAT - Dr. Atanas Dafovski AD Kardzhali, | |
| MHAT Haskovo AD Haskovo, | |
| MHAT Heart and Brain Pleven, | |
| MHAT Heart and Brain EAD Burgas, | |
| MHAT MC-Sv Ivan Rilski EOOD Plovdiv, | |
| MHAT Southwest Hospital OOD Sandanski, | |
| MVZ CCB Frankfurt Und Main-Taunus GbR Frankfurt, | |
| Maasstad Ziekenhuis Rotterdam, | |
| Maine Medical Center Bramhall Portland, Maine | |
| Malla Reddy Narayana Multispeciality Hospital Hyderabad, Telangana | |
| Malla Reddy Narayana Multispeciality Hospital Hyderabad, Telangana | |
| Marengo CIMS Hospital Ahmedabad, Gujarat | |
| Marmara University Medical Faculty Istanbul, | |
| Matsuyama Red Cross Hospital_Department of Cardiovascular Medicine Ehime, | |
| Max Super Speciality Hospital, Saket New Delhi, National Capital Territory of Delhi | |
| Mayo Clinic Arizona Phoenix, Arizona | |
| Mayo Clinic Jacksonville Jacksonville, Florida | |
| McGuire VA Medical Center Richmond, Virginia | |
| McLaren Bay Region Bay City, Michigan | |
| McLaren Greater Lansing Lansing, Michigan | |
| McLaren Macomb Health Care Mount Clemens, Michigan | |
| McLaren Northern MI Hosp Petoskey, Michigan | |
| Meander Medisch Centrum Amersfoort, | |
| MedStar Hlth Res Institute Clinton, Maryland | |
| MedStar Hlth Res Institute Clinton, Maryland | |
| Medical College & Hospital, Kolkata Kolkata, West Bengal | |
| Medical College & Hospital, Kolkata Kolkata, West Bengal | |
| Medicover Hospitals, Visakhapatnam MVP Visakhapatnam, Andhra Pradesh | |
| Medisch Centrum Haaglanden Locatie Westeinde Ziekenhuis The Hague, | |
| Medisch Spectrum Twente Enschede, | |
| Medizinische Hochschule Hannover - Kardiologie und Angiologie Hanover, | |
| Meir MC - Cardiology department Kfar Saba, | |
| Memorial Healthcare Owosso, Michigan | |
| Mercy Gilbert Medical Center Gilbert, Arizona | |
| Mercy Health - St. Vincent Medical Center Toledo, Ohio | |
| Mercy Research Springfield, Missouri | |
| MercyOne NE Iowa Fam Med & Res Waterloo, Iowa | |
| Mersin City Hospital Mersin, | |
| Mersin University Cardiology Mersin, | |
| Methodist Healthcare System of San Antonio San Antonio, Texas | |
| Methodist Physicians Clinic Omaha, Nebraska | |
| MetroHealth Medical Center Cleveland, Ohio | |
| Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A. Athens, | |
| Mhat "Nch" Sofia, | |
| MidMic Medical Cntr - Midland Midland, Michigan | |
| Midwest Cardiovascu Rsrch Foundation Elkhart, Indiana | |
| Midwest Heart and Vascular Specialists Overland Park, Kansas | |
| Midwest Heart and Vascular Specialists Overland Park, Kansas | |
| Miedziowe Centrum Zdrowia s.a. Lubin, | |
| Missouri Cardiovascular Specialist Columbia, Missouri | |
| Mito Saiseikai General Hospital_Cardiology Ibaraki, | |
| Miyazaki Medical Association Hospital Miyazaki, Miyazaki | |
| Miyazaki Medical Association Hospital_Cardiology Miyazaki, Miyazaki | |
| Mobile Heart USA Health Cardiology Clinic Mobile, Alabama | |
| Monument Health Clinical Rsrch Rapid City, South Dakota | |
| Morriston Hospital Swansea, | |
| Moses H. Cone Mem Hosp Greensboro, North Carolina | |
| Mount Sinai Morningside New York, New York | |
| Multi-Profile Hospital For Active Treatment - City Clinic - Sveti Georgi EOOD Montana, | |
| Multicare Health System Tacoma, Washington | |
| Multidisciplinary Hospital For Active Treatment Cardiolife Ltd. Lovech, | |
| Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD Gabrovo, | |
| Multiprofile Hospital For Active Treatment Ivan Skenderov EOOD Gotse Delchev, | |
| Musgrove Park Hospital Taunton, | |
| Myongji Hospital Goyang-si, Gyeonggi-do | |
| NC Heart and Vascular Research Raleigh, North Carolina | |
| NHO Kure Medical Center and Chugoku Cancer Center Kure-shi, Hiroshima, | |
| NUPEC Cardio Belo Horizonte, | |
| NYU Grossman School of Med New York, New York | |
| Nanfang Hospital, Southern Medical University Guangzhou, | |
| Nanfang Hospital, Southern Medical University Guangzhou, | |
| Nanjing Drum Tower Hospital Nanjing, | |
| Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy Warsaw, | |
| National Heart Institute Kuala Lumpur, | |
| National Heart Institute Kuala Lumpur, | |
| National Hospital Organization Kumamoto Medical Center_Cardiology Kumamoto, | |
| Necmettin Erbakan University Hospital Konya, | |
| Nemocnice AGEL Třinec-Podlesí a.s. Třinec, | |
| Nemocnice Na Homolce Prague, | |
| Nemocnice Pardubickeho kraje a.s. Pardubice, | |
| Nemocnice České Budějovice a.s. České Budějovice, | |
| Nepean Hospital Kingswood, New South Wales | |
| New Brunswick Heart Centre Saint John, New Brunswick | |
| New Cross Hospital Wolverhampton, | |
| Niagara Health System St. Catharines, Ontario | |
| Nil Ratan Sircar Medical College and Hospital Kolkata, West | |
| Nimits Hospital Athens, | |
| Nishinomiya Watanabe Cardiovascular Cerebral Center_Cardiovascular Medicine Hyōgo, | |
| Noordwest Ziekenhuisgroep Alkmaar, | |
| Nordsjællands Hospital Hillerød, | |
| North Kansas City Hospital Kansas City, Missouri | |
| North Mississippi Medical Center Tupelo, Mississippi | |
| Northeast Georgia Medical Ctr Gainesville, Georgia | |
| Northern General Hospital Sheffield, | |
| Northern Health Epping, Victoria | |
| Northern Light Eastern Maine Medical Center Bangor, Maine | |
| Novant Hlth Cardio - Kimel Park Winston-Salem, North Carolina | |
| Nuevo Hospital Civil "Dr. Juan I. Menchaca" Guadalajara, Jalisco | |
| Nuevo Hospital Civil "Dr. Juan I. Menchaca" Guadalajara, Jalisco | |
| OLVG Oost Amsterdam, | |
| OSF HealthCare_Cardiovasc Inst Rockford, Illinois | |
| Odense Universitetshospital, Kardiologisk afd. Odense C, | |
| Ondokuz Mayıs Universitesi Tıp Fakültesi Samsun, | |
| Osaka General Medical Center_Cardiology Osaka, | |
| Osmania General Hospital Hyderabad, Telangana | |
| Ospedale Civile dell'Annunziata Cosenza, | |
| Ospedale Isola Tiberina Gemelli Isola Rome, | |
| Ospedale Maggiore Carlo Alberto Pizzardi Bologna, | |
| Ospedale Misericordia Grosseto Grosseto, | |
| Ospedale Policlinico San Martino Genoa, Liguria | |
| Ospedale Sandro Pertini - UOC Cardiologia Rome, | |
| Ospedale Sant'Andrea - Cardiology La Spezia, | |
| Overton Brooks V.A. Medical Center Shreveport, Louisiana | |
| Overton Brooks V.A. Medical Center Shreveport, Louisiana | |
| PUCCAMP - Hospital e Maternidade Celso Pierro Campinas, São Paulo | |
| Pan-Arcadian General Hospital of Tripoli Evangelistria Tripoli, | |
| Parkway Cardiology Associates, PC Oak Ridge, Tennessee | |
| Peking University First Hospital-Cardiology Beijing, Beijing Municipality | |
| Peking University Third Hospital Beijing, | |
| Penn State Hershey Medical Center Hershey, Pennsylvania | |
| Penn State Hlth Holy Spirit Med Ctr Camp Hill, Pennsylvania | |
| PharmaTex Research, LLC Amarillo, Texas | |
| Podhalanski Szpital Specjalistyczny Nowy Targ, | |
| Policlinico Casilino - Cardiologia e UTIC Rome, | |
| Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh Chandigarh, | |
| Prairie Cardiovascular Consultants, Ltd. Springfield, Illinois | |
| Presidio Ospedaliero di Rivoli Rivoli, To | |
| Prince of Wales Hospital_Randwick Randwick, New South Wales | |
| Princess Alexandra Hospital Woolloongabba, Queensland | |
| Princess Alexandra Hospital Woolloongabba, Queensland | |
| Prism Hlth Carolina Card Cons Greenville, South Carolina | |
| ProMedica Toledo, Ohio | |
| Prolato Clinical Research Cntr Houston, Texas | |
| Pusan National University Yangsan Hospital Yangsan, | |
| QE II Health Sciences Centre Halifax, Nova Scotia | |
| Queen Alexandra Hospital Portsmouth, | |
| Queen Alexandra Hospital Portsmouth, | |
| Rabin MC -Beilinson - Cardiac intensive unit Petah Tikva, | |
| Radboudumc Nijmegen, Gelderland | |
| Ramaiah Memorial Hospital Bengaluru, Karnataka | |
| Rambam MC - Cardiac Intensive Care Unit Haifa, | |
| Reading Hospital West Reading, Pennsylvania | |
| Regina General Hospital Regina, Saskatchewan | |
| Regions Hospital Saint Paul, Minnesota | |
| Reid Physician Associates Richmond, Indiana | |
| Renmin Hospital of Wuhan University-Cardiology Wuhan, Hubei | |
| Rhode Island Hospital Providence, Rhode Island | |
| Rhythm Heart Institute Vadodara, Gujarat | |
| Rhön-Klinikum AG - Zentralklinik Bad Berka - Kardiologie Bad Berka, | |
| Rigshospitalet Copenhagen, | |
| Rijnstate Ziekenhuis Arnhem, | |
| Robert Packer Hospital Sayre, Pennsylvania | |
| Robert-Bosch-Krankenhaus GmbH Stuttgart Stuttgart, | |
| Royal Adelaide Hospital Cardiovascular Clinical Trials Adelaide, South Australia | |
| Royal Alexandra Hospital Edmonton, Alberta | |
| Royal Bournemouth Hospital Bournemouth, Dorset | |
| Royal Brisbane and Women's Hospital Herston, Queensland | |
| Royal Brompton and Harefield Hospitals Harefield, Middlesex | |
| Royal Cornwall Hospital (Treliske) Truro, Cornwall | |
| Royal Infirmary of Edinburgh - Cardiology Edinburgh, | |
| Royal Perth Hospital Perth, Western Australia | |
| Royal University Hospital Saskatoon, Saskatchewan | |
| Royal Victoria Regional Health Centre Barrie, Ontario | |
| S Denver Cardiology Associates Littleton, Colorado | |
| S.P. Medical College & Associated Group of Hospitals Bikaner, Rajasthan | |
| SCANMED Spółka Akcyjna Kutno, | |
| SCANMED Spółka Akcyjna Kutno, | |
| SCANMED Spółka Akcyjna Kutno, | |
| SCANMED Spółka Akcyjna Kutno, | |
| SCANMED Spółka Akcyjna Kutno, | |
| SCB Medical College and Hospital Cuttack, Odisha | |
| SHATC - Cardiolife OOD Varna, | |
| SHATC - Medica Kor EAD Rousse, | |
| SHATC - Yambol EAD Yambol, | |
| SMC Heart Institute and IVF Research Centre Raipur, Chhattisgarh | |
| SMS Medical College & Attached Hospitals Jaipur, Rajasthan | |
| Sahyadri Super Speciality Hospital Pune, | |
| Saint Elizabeth Medical Center Edgewood, Kentucky | |
| Saint Joseph's Hospital Health Center Liverpool, New York | |
| Saint Paul's Hospital Vancouver, British Columbia | |
| Saint Thomas Hospital Nashville, Tennessee | |
| Saiseikai Yokohamashi Nanbu Hospital_Cardiology Yokohama-shi, Kanagawa, | |
| Saiseikai Yokohamashi Tobu Hospital_Cardiology Kanagawa, | |
| Samodzielny Publiczny Specjalistyczny Szpital Zachodni Im.Sw.Jana Pawla II Grodzisk Mazowiecki, | |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych i Administracji w Rzeszowie Rzeszów, Podkarpackie Voivodeship | |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie Krakow, | |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Pulawach Puławy, Lublin Voivodeship | |
| Samodzielny Publiczny Zespol Opieki Zdrowotnej w Swidnicy Swidnica, | |
| Samodzielny Publiczny Zespol Opieki Zdrowotnej w Swidnicy Swidnica, | |
| Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej w Ostrowi Mazowieckiej Ostrów Mazowiecka, | |
| San Diego Cardiac Center San Diego, California | |
| San Francisco V.A. Medical Center San Francisco, California | |
| Sanatorio Finochietto Buenos Aires, | |
| Sanatorio Finochietto Buenos Aires, | |
| Sanatorio Güemes CABA, City of Buenos Aires | |
| Sanatorio Modelo Quilmes Quilmes, Buenos Aires | |
| Sanatorio Parque Rosario, Santa Fe Province | |
| Sanford Health - Fargo Fargo, North Dakota | |
| Sanford Health - Fargo Fargo, North Dakota | |
| Sanford Research Sioux Falls, South Dakota | |
| Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow, Uttar Pradesh | |
| Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow, Uttar Pradesh | |
| Sarawak Heart Centre Kota Samarahan, Sarawak | |
| Sardar Vallabhbhai Patel Institute of Medical Sciences and Research Ahmedabad, Gujarat | |
| Sentara Bayside Hospital Norfolk, Virginia | |
| Seoul National University Bundang Hospital Seongnam-si, | |
| Seoul National University Hospital Seoul, | |
| Servicios Integrales Nova de Monterrey San Nicolás de los Garza, | |
| Servicios Integrales Nova de Monterrey San Nicolás de los Garza, | |
| Seth GS Medical College & KEM Hospital Mumbai, Maharashtra | |
| Severance Hospital, Yonsei University Health System Seoul, | |
| Shamir MC - Cardio and Pedi Beer Yaakov, | |
| Sheba MC - Cardiology Clinical Research Unit Tel Litwinsky, | |
| Shengjing Hospital of China Medical University Shenyang, | |
| Shengjing Hospital of China Medical University-Cardiology Shenyang, Liaoning | |
| Shiga University of Medical Science Hospital_Cardiology Shiga, | |
| Shri B. D. Mehta Mahavir Heart Institute Surat, Gujarat | |
| Shri Krishna Hrudayalaya & Critical Care Centre Nagpur, Maharashtra | |
| Shri Mahant Indiresh Hospital Dehradun, Uttarakhand | |
| Sichuan Provincial People's Hospital-Cardiology Chengdu, Sichuan | |
| Sir Ganga Ram Hospital New Delhi, National Capital Territory of Delhi | |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou, | |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou, | |
| Sismanogleio General Hospital Marousi, | |
| Sourasky MC - Cardio Vascular Research Center Tel Aviv, | |
| South Oklahoma Heart Research, LLC Oklahoma City, Oklahoma | |
| South Oklahoma Heart Research, LLC Oklahoma City, Oklahoma | |
| Southlake Regional Hlth Centre Newmarket, Ontario | |
| Specialized Hospital For Active Cardiology Treatement Cardiolife OOD Varna, | |
| Specjalistyczny Szpital Im. E. Szczeklika W Tarnowie Tarnów, | |
| Specjalistyczny Szpital Im. E. Szczeklika W Tarnowie Tarnów, | |
| Specjalistyczny Szpital Miejski im. M.Kopernika w Toruniu Torun, | |
| Sri Jayadeva Institute of Cardiovascular Sciences & Research Bengaluru, Karnataka | |
| Sri Ramachandra Medical Centre Chennai, Tamil Nadu | |
| Sri Ramachandra Medical Centre Chennai, Tamil Nadu | |
| Ss. Annunziata Chieti, Abruzzo | |
| St Francis Hospital Lindner Research Center Roslyn, New York | |
| St Francis Hospital Lindner Research Center Roslyn, New York | |
| St. Boniface Hospital Winnipeg, Manitoba | |
| St. Boniface Hospital Winnipeg, Manitoba | |
| St. Luke's Idaho Cardiology Associates Meridian, Idaho | |
| St. Michael's Hospital Toronto, Ontario | |
| St.Jude Clin-NovantHemby Child Charlotte, North Carolina | |
| St.Mary's Hospital_Cardiology Fukuoka, | |
| Sterling Hospitals, Race Course Road Vadodara, Gujarat | |
| Stony Brook University Hospital Stony Brook, New York | |
| Städt. Klinikum Dresden - 2. Medizinische Klinik Dresden, | |
| Sultan Ahmad Shah Medical Centre @IIUM Kuantan, Pahang | |
| Sunnybrook Health Sciences Centre Toronto, Ontario | |
| Sunshine Coast University Hospital Birtinya, | |
| Sunshine Hospital St Albans, Victoria | |
| Swedish Medical Center_Seattle Seattle, Washington | |
| Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o. Warsaw, | |
| Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o. Warsaw, | |
| Szpital Miejski Nr 4 w Gliwicach Sp. z o.o., Oddzial Kardiologii Gliwice, Silesian Voivodeship | |
| Szpital Uniwersytecki Nr 2 im. Dr. Jana Biziela Bydgoszcz, | |
| Szpital Wolski im. dr Anny Gostyńskiej Sp. z o.o. Warsaw, | |
| Szpitale Pomorskie Sp. z o.o. Gdynia, Pomeranian Voivodeship | |
| T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan Adana, | |
| TEDA International Cardiovascular Hospital-Cardiovascular Tianjin, Tianjin Municipality | |
| Teda International Cardiovascular Hospital Tianjin, Tianjin Municipality | |
| Teikyo University Hospital_Cardiology Tokyo, | |
| Tennova HC Turkey Creek MC Knoxville, Tennessee | |
| Tergooi, locatie Hilversum Hilversum, | |
| Texas Heart Inst Medical Ctr Houston, Texas | |
| The 1st Affiliated Hospital of WMU-Cardiology Wenzhou, Zhejiang | |
| The Alfred Hospital Melbourne, Victoria | |
| The Catholic University of Korea, Bucheon St. Mary's Hospital Bucheonsi Weonmigu, | |
| The Catholic University of Korea, Seoul St. Mary's Hospital Seoul, | |
| The First Affiliated Hospital of Harbin Medical University Harbin, | |
| The First Affiliated Hospital of Harbin Medical University Harbin, | |
| The First Affiliated Hospital of WMU-Cardiology Wenzhou, Zhejiang | |
| The First Affiliated Hospital of Xi'an Jiaotong University-Cardiovascular Xi'an, Shaanxi | |
| The First Affiliated hospital of Fujian Medical University Fuzhou, Fujian | |
| The Heart House Haddon Heights Haddon Heights, New Jersey | |
| The James Cook University Hospital Middlesbrough, | |
| The Madras Medical Mission Chennai, Tamil Nadu | |
| The New York Hospital Brooklyn, New York | |
| The People's Hospital of Guangxi Zhuang Autonomous Region Nanning, Guangxi | |
| The People's Hospital of Liaoning Province Shenyang, Liaoning | |
| The People's Hospital of Liaoning Province-Cardiology Shenyang, Liaoning | |
| The Prince Charles Hospital Chermside, Queensland | |
| The Sakakibara Heart Institute of Okayama_Department of Cardiovascular Medicine Okayama, | |
| The Second Affiliated Hospital Of Chongqing Medical University Chongqing, Chongqing Municipality | |
| The Second Affiliated Hospital of Nanjing Medical university Nanjing, | |
| The Second Xiangya Hospital of Central South University Changsha, | |
| Tianjin People's Hospital Tianjin, Tianjin Municipality | |
| Toho University Sakura Medical Center_Cardiology Chiba, | |
| Tohoku University Hospital, Cardiovascular Sendai-shi, Miyagi, | |
| Tokai University Hospital_Cardiology Kanagawa, | |
| Tokai University Hospital_Cardiology Kanagawa, | |
| Tokat Gaziosmanpaşa Üniversitesi Tıp Fakültesi Hastanesi Tokat Province, | |
| Tokushima Prefectural Central Hospital_Cardiology Tokushima, | |
| Torbay Hospital Torquay, | |
| Torrance Memorial Medical Center Torrance, California | |
| Townsville University Hospital Douglas, | |
| Trakya University Edirne, | |
| Trinity Health Michigan Heart Ypsilanti, Michigan | |
| Trinity Health Oakland Hospital Pontiac, Michigan | |
| Trinity Medical Group Minot, North Dakota | |
| Trinity Medical WNY, PC Buffalo, New York | |
| Tsuchiura Kyodo General Hospital_Internal Medicine Ibaraki, | |
| Tsukuba Medical Center Hospital_Department of Cardiology Tsukuba-shi, Ibaraki, | |
| Tzaneio General Hospital of Piraeus Piraeus, | |
| U.G.H of Athens "Attikon" Chaidari, Athens, | |
| UCSD Medical Center San Diego, California | |
| UF Hlth Jacksonville Jacksonville, Florida | |
| UHN-Toronto General Hospital Toronto, Ontario | |
| UHN-Toronto General Hospital Toronto, Ontario | |
| UMC Groningen Groningen, | |
| UMC of Southern Nevada Las Vegas, Nevada | |
| UMHAT "Deva Maria" EOOD Burgas, | |
| UMHAT "Sveta Marina" EAD Varna, | |
| UMHAT Pulmed, Department of Cardiology Plovdiv, | |
| UMHAT Sofiamed Sofia, | |
| UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Cardiology Plovdiv, | |
| UNC Hospital HVC_Meadowmont Chapel Hill, North Carolina | |
| UT Health University of Texas Houston, Texas | |
| Unidad Medica de Alta Especialidad No. 71 IMSS Torreón, Coahuila | |
| Unidad Medica de Alta Especialidad No. 71 IMSS Torreón, Coahuila | |
| Uniklinik Klinikum Bielefeld - Kardiologie und Internist. Intensivmedizin Bielefeld, | |
| Uniklinik Regensburg - Innere Medizin II Regensburg, | |
| Uniklinik TU Dresden - Herzzentrum Dresden GmbH Dresden, | |
| Uniklinik Tübingen - Innere Med. III Kardiologie und Angiologie Tübingen, | |
| UniklinikHeidelberg - Innere Med. III - Kardiologie, Angiologie, Pneumologie Heidelberg, | |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology-Cardiology Wuhan, Hubei | |
| Univ Gen Hospital Larisa, Cardiology Medicine Clinic Larissa/Thessaly, Greece | |
| Univ of Alberta Hosp Edmonton Edmonton, Alberta | |
| Univ of Mississippi Med Center Jackson, Mississippi | |
| Universiti Teknologi MARA, Sungai Buloh Campus Sungai Buloh, Selangor | |
| University General Hospital of Ioannina,Internal Medicine Ioannina, | |
| University General Hospital of Ioannina,Internal Medicine Ioannina, | |
| University Hospitals of Cleveland Medical Center Elyria, Ohio | |
| University Malaya Medical Centre Kuala Lumpur, | |
| University Medical Center New Orleans New Orleans, Louisiana | |
| University Multidisciplinary Hospital for Active Treatment Sveta Ekaterina EAD Sofia, | |
| University Of Washington_Seattle Seattle, Washington | |
| University of CO - Division of Cardiology Aurora, Colorado | |
| University of Californ LA-UCLA Los Angeles, California | |
| University of California Irvine Irvine, California | |
| University of Cincinnati/UC Health Cincinnati, Ohio | |
| University of Florida Gainesville, Florida | |
| University of Kansas Hospital Kansas City, Kansas | |
| University of Louisville Louisville, Kentucky | |
| University of Ottawa Heart Ins Ottawa, Ontario | |
| University of Rochester Rochester, New York | |
| University of Texas Medical Branch Galveston, Texas | |
| University of Texas Southwestern Medical Center Dallas, Texas | |
| University of Toledo Toledo, Ohio | |
| University of Virginia Charlottesville, Virginia | |
| Universitätsklinikum Düsseldorf - Klinik für Kardiologie, Pneumologie und Angiologie Düsseldorf, | |
| Universitätsklinikum Frankfurt aM - Kardiologie Frankfurt am Main, | |
| Universitätsklinikum Freiburg - Medical Center Freiburg im Breisgau, | |
| Universitätsklinikum Hamburg-Eppendorf - University Medical Center Hamburg-Eppendorf Hamburg, | |
| Universitätsklinikum Leipzig - Klinik und Poliklinik für Kardiologie Leipzig, | |
| Universitätsklinikum Mannheim - 1. Medizinische Klinik Mannheim, | |
| Uniwersytecki Szpital Kliniczny Nr 2 PUM W Szczecinie Szczecin, | |
| Uniwersytecki Szpital Kliniczny W Poznaniu Poznan, | |
| Uniwersytecki Szpital Kliniczny W Poznaniu Poznan, | |
| Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Łodzi Lodz, | |
| Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok, | |
| Uniwersytecki Szpital Kliniczny w Opolu Opole, | |
| Uniwersytecki Szpital Kliniczny w Opolu Opole, | |
| Uniwersyteckie Centrum Kliniczne (UCK) Gdansk, | |
| Uniwersyteckie Centrum Kliniczne WUM Warsaw, | |
| Uniwersyteckie Centrum Kliniczne WUM Warsaw, | |
| VA Greater Los Angeles Hlthcare System Los Angeles, California | |
| VA Medical Center_Minneapolis Minneapolis, Minnesota | |
| VA Medical Center_Salem Salem, Virginia | |
| Valley Clinical Trials Covina, California | |
| Valley Clinical Trials Covina, California | |
| Valley Health Link Winchester, Virginia | |
| Vancouver General Hospital Vancouver, British Columbia | |
| Vanderbilt University Medical Center Nashville, Tennessee | |
| Vanderbilt University Medical Center Nashville, Tennessee | |
| Vardhaman Mahavir Medical College & Safdarjung Hospital New Delhi, National Capital Territory of Delhi | |
| Vijan Hospital & Research Centre Nashik, Maharashtra | |
| Virginia Commonwealth University Health System Richmond, Virginia | |
| Virtua Health Camden, New Jersey | |
| WMU Homer Stryker MD School of Medicine Kalamazoo, Michigan | |
| Wake Forest Uni Hlth Sciences High Point, North Carolina | |
| Washington University School of Medicine_St. Louis St Louis, Missouri | |
| Wayne State University/University Health Center Detroit, Michigan | |
| West China Hospital Sichuan University-Cardiology Chengdu, Sichuan | |
| Westchester Medical Center Valhalla, New York | |
| Westchester Medical Center Valhalla, New York | |
| William Harvey Hospital Ashford, Kent | |
| William Harvey Hospital Ashford, Kent | |
| William Osler Hel Bra Civic Hs Brampton, Ontario | |
| Winter Haven Hospital Winter Haven, Florida | |
| Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu Przemyśl, | |
| Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej Biała Podlaska, | |
| Wojewodzki Szpital Specjalistyczny We Wroclawiu Wroclaw, | |
| Wojewodzki Szpital Specjalistyczny We Wroclawiu Wroclaw, | |
| Wojewodzki Szpital Zespolony W Elblagu samodzielny publiczny zakład opieki zdrowotnej Elblag, | |
| Wojewodzki Szpital Zespolony W Elblagu samodzielny publiczny zakład opieki zdrowotnej Elblag, | |
| Wojewódzki Specjalistyczny Szpital im.Wl. Bieganskiego, Lodz, | |
| Wojewódzki Specjalistyczny Szpital im.Wl. Bieganskiego, Lodz, | |
| Wojewódzki Szpital Specjalistyczny im. NMP w Częstochowie Częstochowa, | |
| Wojewódzki Szpital Zespolony im. dr. Romana Ostrzyckiego w Koninie Konin, | |
| Wolfson MC - The Heart Institute Holon, | |
| Wonju Severance Christian Hospital Gangwon-do, | |
| Wright State University Fairborn, Ohio | |
| Xiangya Hospital Central-South University Changsha, Hunan | |
| Yale Ctr for Clin Invest New Haven, Connecticut | |
| Yokohama City University Hospital Kanagawa, | |
| Yokohama City University Medical Center_Cardiovascular Center Kanagawa, | |
| Yokohama Municipal Citizen's Hospital_Cardiology Kanagawa, | |
| Zespol Zakladow Opieki Zdrowotnej w Ostrowie Wielkopolskim Ostrów Wielkopolski, Greater Poland Voivodeship | |
| Zespół Zakładów Opieki Zdrowotnej w Ostrowie Wielkopolskim Ostrów Wielkopolski, Greater Poland Voivodeship | |
| Zhejiang Hospital, Zhejiang University School of Medicine Hangzhou, | |
| Zhejiang Hospital-Cardiology Hangzhou, Zhejiang | |
| Zhongda Hospital Southeast University Nanjin, | |
| Zhongda Hospital, Southeast University Nanjing, | |
| Zhongshan Hospital, Fudan University-Cardiology Shanghai, Shanghai Municipality | |
| Śródmiejskie Centrum Kliniczne,II Oddział Kardiologii MSB, Klinika Chorób Serca CMKP Warsaw, |
The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation (REACT-AF)
Shea Smith - reactaf_stanfordcc@stanford.edu
NCT05836987
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• 22-85 years of age.
• English speaking participants. Spanish-only speakers may be included in the future at select sites appropriately translated.
• History of non-permanent atrial fibrillation.
• CHA2DS2-VASC score of 1-4 for men and 2-4 for women without prior stroke or Transient Ischemic Attack (TIA), The CHA2DS2-VASc score is a point-based system used to stratify the risk of stroke in Atrial Fibrillation (AF) patients. The acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female). Congestive heart failure defined as: The presence of signs and symptoms of either right (elevated central venous pressure, hepatomegaly, dependent edema) or left ventricular failure (exertional dyspnea, cough, fatigue, orthopnea, paroxysmal nocturnal dyspnea, cardiac enlargement, rales, gallop rhythm, pulmonary venous congestion) or both, confirmed by non-invasive or invasive measurements demonstrating objective evidence of cardiac dysfunction and/or ejection fraction \< 40%.
• The participant is on a DOAC at the time of screening and willing to stay on DOAC for duration of study.
• Willing and able to comply with the protocol, including: * Possession of a smart watch-compatible smart phone (iPhone that supports the latest shipping iOS) with a cellular service plan * Be willing to wear the smart watch for the suggested minimum of 14 hours a day * Expected to be within cellular service range at least 80% of the time
• Willing and able to discontinue DOAC
• The participant is willing and able to provide informed consent.
Exclusion Criteria:
• Valvular or permanent atrial fibrillation.
• Current treatment with warfarin and unwilling or unable to take a DOAC.
• The participant is a woman who is pregnant or nursing.
• The participant is being treated with chronic aspirin, another anti-platelet agent, or chronic NSAIDS outside of current medical guidelines (e.g., primary stroke prevention in patients with atrial fibrillation, primary prevention of cardiovascular events, pain relief, fever, gout) and is unwilling or unable to discontinue use for the study duration.
• Existing cardiac rhythm device or indication for a permanent pacemaker, Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT) device or planned insertable cardiac monitor. Insertable cardiac monitors are permitted unless they are being used to guide anticoagulation treatment.
• Known or suspected symptomatic or asymptomatic atrial fibrillation lasting ≥ 1 hour/month over the last 3 months.
• Any documented single AF episode lasting ≥ 1 hour on standard of care or study-provided external cardiac monitor of \> 6 days duration performed within 45 days prior to randomization. Shorter monitoring durations may be acceptable for inclusion at the discretion of the site PI based on the totality of monitoring data and approval of the study PI.
• Ablation for AF within the last 2 months.
• Prior or anticipated left atrial appendage occlusion or ligation.
• Mechanical prosthetic valve(s) or severe valve disease.
• Hypertrophic cardiomyopathy.
• Participant needs DOAC for reasons other than preventing stroke or arterial embolism resulting from AF (i.e., preventing Deep Vein Thrombosis (DVT) or PE) or needs permanent OAC (i.e., congenital heart defects, prosthetic heart valve).
• Participants deemed high risk for non-cardioembolic stroke (i.e., significant carotid artery disease defined as stenosis \> 75%) based on the investigator's discretion.
• The participant is enrolled, has participated within the last 30 days, or is planning to participate in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from the study manager; there is no concern that co-enrollment could confound the results of this trial.
• The participant has a tattoo, birthmark, or surgical scar over the dorsal wrist area on the ipsilateral side that the AFSW may be worn.
• The participant has a tremor on their ipsilateral side that the AFSW may be worn.
• Any concomitant condition that, in the investigator's opinion, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).
• Known hypersensitivity or contraindication to direct oral anticoagulants.
• Documented prior stroke (ischemic or hemorrhagic) or transient ischemic attack.
• Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism). AF ablation does not constitute reversible AF.
• \> 5% burden of premature atrial or ventricular depolarizations on pre-enrollment cardiac monitoring.
• History of atrial flutter that has not been treated with ablation (participants in atrial flutter and have been ablated are eligible for enrollment).
• Stage 4 or 5 chronic kidney disease.
• Conditions associated with an increased risk of bleeding: * Major surgery in the previous month * Planned surgery or intervention in the next three months that would require cessation of anticoagulation \> 2 weeks. * History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intra- articular bleeding * Gastrointestinal hemorrhage within the past year unless the cause has been permanently eliminated (e.g., by surgery) * Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days * Hemorrhagic disorder or bleeding diathesis * Need for anticoagulant treatment for disorders other than AF * Uncontrolled hypertension (Systolic Blood Pressure \>180 mmHg and/or Diastolic Blood Pressure \>100 mmHg)
DEVICE: AFSW Guided DOAC, DRUG: Continuous DOAC therapy
Atrial Fibrillation
Atrial Fibrillation, Anticoagulation, AF-sensing Smart Watch, Ischemic Stroke, Systemic Embolism
I'm interested
Share via email
Show 85 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Advanced Heart and Vascular Institute of Hunterdon Flemington, New Jersey | Alexis Bellafiore - (abellafiore@ahvi-nj.com) |
| Alexian Brothers Health System Elk Grove Village, Illinois | Dina Yassan - (dina.yassen@ascension.org) Elizabeth Hejna - (ehejna@buffalo.edu) |
| Allegheny Singer Research Institute Pittsburgh, Pennsylvania | Caitlin Phalunas - (caitlin.phalunas@ahn.org) Minesh Lathia - (minesh.lathia@ahn.org) |
| Ascension St. Vincent Indianapolis, Indiana | Regina Margiotti - (regina.margiotti@ascension.org) Ann Renick - (anne.renick@ascension.org) |
| Banner University Phoenix, Arizona | Yi Dai - (daliseshatz@arizona.edu) Raeven Maxwell - (raeven.maxwell@bannerhealth.com) |
| BayCare Health Systems Clearwater, Florida | Karen Herring - (karen.herring@baycare.org) |
| Baycare Health Systems Clearwater Winter Haven, Florida | Amanda Steadham - (Amanda.Steadham@baycare.org) Lynda Argenzio - (lynda.argenzio@baycare.org) |
| Baylor College of Medicine Houston, Texas | Stephen Harold - (harold@bcm.edu) |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | Jenifer M Kaufman - (jmkaufma@bidmc.harvard.edu) Patricia Tyler - (ptyler@bidmc.harvard.edu) |
| Boston Medical Center Boston, Massachusetts | Laura Gavrilles - (laura.gavrilles@bmc.org) |
| Brigham and Women's Hospital Boston, Massachusetts | Carlos Matostirado - (cmatostirado@bwh.harvard.edu) Carlos Patino Rivas - (cpatinorivas@bwh.harvard.edu) |
| Cleveland Clinic Florida Weston, Florida | Angelic Gamez - (gameza3@ccf.org) Ashley Pastorius - (pastora3@ccf.org) |
| Columbia University Medical Center New York, New York | Esteban Ceballos - (ec3539@cumc.columbia.edu) |
| Corewell Health (Former Spectrum Health) Grand Rapids, Michigan | Lisa Van Loo - (lisa.vanloo@spectrumhealth.org) Meaghan Redmond - (meaghan.redmond@spectrumhealth.org) |
| Emory University Atlanta, Georgia | Thomas Preiser - (tpreise@emory.edu) |
| Essentia Health The Duluth Clinic Duluth, Minnesota | Allise Taran - (allise.taran@essentiahealth.org) |
| Georgia Arrhythmia Consultants and Research Institute Warner Robins, Georgia | Simisola Oludare - (soludare@gacri.com) |
| Hackensack Meridian Health Hackensack, New Jersey | Patricia Arakelian - (Patricia.Arakelian@hmhn.org) |
| Hennepin Healthcare Research Institute Minneapolis, Minnesota | Zakiya Johnson - (zjohnson@bermancenter.org) |
| Henry Ford Health Detroit, Michigan | Briita Wanhala - (bwanhal1@hfhs.org) Danielle Delmotte - (ddelmot2@hfhs.org) |
| Houston Methodist Hospital Houston, Texas | Chinwe Ngumezi - (ccngumezi@houstonmethodist.org) |
| Johns Hopkins Univeristy Baltimore, Maryland | Michele Martucci - (mmill148@jhmi.edu) Natalie Horstman - (nhorstm3@jhu.edu) |
| Lahey Hospital & Medical Center Burlington, Massachusetts | Jean Byrne - (jean.byrne@lahey.org) |
| Loyola University Chicago Chicago, Illinois | Nancy Schoenecker - (nschoenecker@luc.edu) Jean Del Priore - (jdelpri@luc.edu) |
| MUSC Health Heart and Vascular Columbia, South Carolina | Jacqueline Sheriod-Scott - (sheriods@musc.edu) |
| Maine Medical Partners MaineHealth Cardiology Scarborough, Maine | Hilary Curtis - (hilary.curtis@mainehealth.org) Brenda Galsgow - (brenda.glasgow@mainehealth.org) |
| Mayo Clinic Rochester, Minnesota | Federico Rey Simon - (Simon.FedericoRey@mayo.edu) |
| Medical College of Wisconsin Froedtert Hospital Milwaukee, Wisconsin | Shelley Schultz - (sschultz@mcw.edu) Debbi Hoff - (dhoff@mcw.edu) |
| Medical Faculty Associates George Washington University Washington D.C., District of Columbia | Alfateh Sidahmed - (asidahmed@mfa.gwu.edu) Catherine Cantlay - (ccantlay@mfa.gwu.edu) |
| Medical University of South Carolina Charleston, South Carolina | Jeffrey Winterfield - (winterfj@musc.edu) |
| Midwest Cardiovascular Institute Naperville, Illinois | Josilyn Klimek - (Josilyn.Klimek@cardio.com) |
| NYU Langone Health New York, New York | Wendy Drewes - (wendy.drewes@nyulangone.org) Elizabeth Wolfrom - (Elizabeth.Wolfrom@nyulangone.org) |
| NewYork Presbyterian - Queens Queens, New York | Bo Lwin - (bol9009@nyp.org) |
| NorthShore University Healthsystem Evanston, Illinois | Marisa Durante - (mdurante@northshore.org) |
| Northwestern University Chicago, Illinois | BCVI Clinical Trials Unit - (heartresearch@northwestern.edu) |
| Ohio State University Medical Center Columbus, Ohio | Ciara Duffy - (Ciara.Duffy@osumc.edu) |
| Penn State Health Medical Group Berks Cardiology Wyomissing, Pennsylvania | Emese Futchko - (efutchko@pennstatehealth.psu.edu) Michelle Feltenberger - (mfeltenberger@pennstatehealth.psu.edu) |
| Presbyterian Healthcare Services Albuquerque, New Mexico | Kristin Flores - (kflores15@phs.org) Avalon Abrums - (aabrums3@phs.org) |
| Rhode Island Hospital Providence, Rhode Island | Catherine Gordon - (cgordon@lifespan.org) |
| Rush University Medical Center Chicago, Illinois | Nusrat Jahan - (nusrat_jahan@rush.edu) Mary Ann Donahue - (mary_a_donahue@rush.edu) |
| Rutgers, the State University of New Jersey Piscataway, New Jersey | Glaucia Dos Santos-Vaccaro - (gd301@rwjms.rutgers.edu) Nivedita Rajiv - (nr505@rwjms.rutgers.edu) |
| Sarasota Memorial Health Care System Sarasota, Florida | Alexandra Gardner - (Alexandra-Gardner@smh.com) |
| Scripps Health San Diego, California | Carolina Robertson - (Robertson.Carolina@scrippshealth.org) Alison Walton - (Walton.Alison@scrippshealth.org) |
| South Denver Cardiology Associates, P.C. Littleton, Colorado | Mary Soltau - (msoltau@southdenver.com) |
| St. Elizabeth's Medical Center Washington D.C., District of Columbia | Rina Vaquerano - (rina.vaquerano@steward.org) |
| St. Joseph Medical Center Tacoma Tacoma, Washington | Jacqueline Lusk - (Jacquelyn.Lusk@commonspirit.org) |
| Stanford University Palo Alto, California | Diona Gjermeni - (gjermeni@stanford.edu) |
| Staten Island University Hospital-Northwell Health Staten Island, New York | Alexandra Pantea - (apantea@northwell.edu) |
| Stony Brook University Stony Brook, New York | Melanie Rooney - (melanie.rooney@stonybrookmedicine.edu) Michelle Xikis - (Michele.xikis@stonybrookmedicine.edu) |
| Texas Cardiac Arrhythmia Research Foundation Austin, Texas | Deb Cardinal - (dscardinal@austinheartbeat.com) |
| The Lindner Center for Research and Education at The Christ Hospital Cincinnati, Ohio | Erica Jones - (Erica.Jones@thechristhospital.com) Rebecca Harper - (RebeccaM.Harper@thechristhospital.com) |
| The Valley Hospital, Inc. Paramus, New Jersey | Kathleen Sayles - (ksayles@valleyhealth.com) |
| Thomas Jefferson University Philadelphia, Pennsylvania | Mckenna Krall - (mckenna.krall@jefferson.edu) |
| Trinity Health Grand Rapids/Mercy Health Grand Rapids, Michigan | Lucas Vermaire - (Lucas.vermaire@trinity-health.org) Nicolina Evola - (Nicolina.evola@trinity-health.org) |
| Trinity Health Michigan Heart - Ann Arbor Ypsilanti, Michigan | Autumn Howe - (ahowe@michiganheart.com) Bozhena Stakh - (bozhena_stakh@michiganheart.com) |
| Tufts Medical Center Boston, Massachusetts | Nadia Bokhari - (Nadia.Bokhari@tuftsmedicine.org) |
| UC Davis Health Sacramento, California | Maryfel Llanillo - (mlparaiso@ucdavis.edu) |
| UMass Chan Medical School Worcester, Massachusetts | Shanna Spencer - (shanna.spencer@umassmed.edu) Aditi Singh - (Aditi.Singh7@umassmed.edu) |
| University Health Truman Medical Center Kansas City, Missouri | |
| University at Buffalo Buffalo, New York | Courtney Bishop - (cabishop@buffalo.edu) Elizabeth Hejna - (ehejna@buffalo.edu) |
| University of California Los Angeles (UCLA Health) Los Angeles, California | Zackary Ortega - (zmortega@mednet.ucla.edu) Monserrath Campos - (monserrathcampos@mednet.ucla.edu) |
| University of Chicago Chicago, Illinois | Shahram Sarrafi - (ssarrafi1@uchicagomedicine.org) |
| University of Cincinnati College of Medicine Cincinnati, Ohio | Rachel Mardis - (rachael.mardis@uc.edu) Carol Knochelmann - (carol.knochelmann@uc.edu) |
| University of Colorado Aurora, Colorado | Megan Collett - (megan.collett@uchealth.org) Tiffany Herrera - (tiffany.herrera@uchealth.org) |
| University of Florida Gainesville, Florida | Sarah Long - (Sarah.Long@medicine.ufl.edu) Janette Bostick - (Janette.Bostick@medicine.ufl.edu) |
| University of Illinois Chicago Chicago, Illinois | Muriel Chen - (yining@uic.edu) Jood Dabbas - (jdabbas@uic.edu) |
| University of Iowa Hospitals and Clinics Iowa City, Iowa | Trisha Elliott - (trisha-elliott@uiowa.edu) |
| University of Miami - Leonard S. Miller SOM Miami, Florida | Carmen Maria Baez-Garcia - (cbaezgarcia@med.miami.edu) |
| University of Minnesota Minneapolis, Minnesota | Julie Dicken - (dicke022@umn.edu) Maddy Chopp - (Chopp015@umn.edu) |
| University of New Mexico Health Sciences Center Albuquerque, New Mexico | Alexandra Yingling - (avyingling@salud.unm.edu) |
| University of North Carolina Chapel Hill, North Carolina | Meghan Allen - (meghme@med.unc.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Natalia Serrano - (natalia-wellsserrano@ouhsc.edu) Aurora Vera - (aurora-vera@ouhsc.edu) |
| University of Southern California - Keck School of Medicine Los Angeles, California | Preetha Ramanarayan - (preetha.ramanaranyan@med.usc.edu) Stephanie Chao - (Stephanie.Chao@med.usc.edu) |
| University of Texas Health Science Center at Houston Houston, Texas | Anna Menezes - (anna.m.menezes@uth.tmc.edu) |
| University of Texas Southwestern Medical Center Dallas, Texas | Vukile Mlambo - (vukile.mlambo@utsouthwestern.edu) |
| University of Virginia Charlottesville, Virginia | Spencer Dennis - (gvj4ky@virginia.edu) |
| University of Wisconsin Madison, Wisconsin | Karen Olson - (kjolson@medicine.wisc.edu) Josh Hall - (jjhall@medicine.wisc.edu) |
| Virginia Commonwealth University Richmond, Virginia | Esoterica Berry - (esoterica.berry@vcuhealth.org) Mait Innes - (david.innes@vcuhealth.org) |
| Wake Forest Baptist Health Winston-Salem, North Carolina | Keishia Rodriguez - (kyrodrig@wakehealth.edu) |
| Washington University School of Medicine St Louis, Missouri | Janice Amsler - (jmamsler@wustl.edu) Sharon Heuerman - (sheuerman@wustl.edu) |
| Weill Medical College of Cornell University New York, New York | Dolores Reynolds - (dtr2001@med.cornell.edu) |
| Westchester Medical Center Valhalla, New York | Fnu Namrata - (fnu.namrata@wmchealth.org) Erida Castro-Rivas - (Erida.Castro@wmchealth.org) |
| White Plains Hospital White Plains, New York | Aileen Ferrick - (aferrick@wphospital.org) Uloma Ijomah - (uijomah@wphospital.org) |
| William Beaumont Hospital Royal Oak, Michigan | Jon Teefey - (Jon.teefey@beaumont.org) Lauren Scribner - (Lauren.scribner@beaumont.org) |
| Wooster Community Hospital Wooster, Ohio | Erica Stahl - (estahl@wchosp.org) |
Left vs Left Randomized Clinical Trial
Mihail G Chelu, MD, PhD - leftvsleft@bcm.edu
NCT05650658
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Men and women 18 years of age or older.
* A LVEF ≤ 50% within 6 months prior to enrollment.
* Resting QRS duration ≥130 ms as evidenced by a historical 12-lead ECG prior to enrollment OR anticipated right ventricular pacing \>40% OR device in place with right ventricular pacing \> 40%.
* Are optimized on HF guideline directed medical therapy according to current HF published guidelines OR patient's physician will make an effort to start all guideline-directed medical therapy and titrate doses up as permitted by the participant clinical status and co-morbidities prior to implantation procedure.
Exclusion Criteria:
* Women who are pregnant, lactating, or plan to become pregnant during the course of the trial.
* Participants with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary, intervention in the next three (3) months.
* Enzyme-positive myocardial infarction within the past three (3) months prior to enrollment.
* Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past three (3) months prior to enrollment.
* Reversible non-ischemic cardiomyopathy (e.g., acute viral myocarditis).
* Participants with Chagas disease, cardiac sarcoidosis or amyloidosis.
* Expected to receive left ventricular assist device or heart transplantation within 6 months.
* Participants with primary severe valvular disease (e.g., aortic stenosis).
* Have a life expectancy of less than 12 months.
* Participants with irreversible brain damage from preexisting cerebral disease.
* Participants with a contrast dye allergy unable or unwilling to undergo pretreatment with steroids and/or diphenhydramine.
* Participants participating in any other interventional cardiovascular clinical trial.
* Participants who would be unable to comply with the study's follow-up visit schedule; or
* Participants who had any prior unsuccessful attempt at implantation of biventricular pacing (BiVP), His Bundle Pacing (HBP), or Left Bundle Branch Pacing (LBBP) device. DEVICE: His/LBBP, DEVICE: BiVP
Heart Failure, Heart Failure With Reduced Ejection Fraction, AV Block, LBBB, RBBB, Intraventricular Conduction Delay, Pacing-Induced Cardiomyopathy
I'm interested
Share via email
Show 71 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Allegheny-Singer Research Institute Pittsburgh, Pennsylvania | Minesh Lathia - (minesh.lathia@ahn.org) |
| Baptist Health Louisville Louisville, Kentucky | Karin Cryan - (karin.cryan@BHSI.COM) |
| Baylor College of Medicine Houston, Texas | Stephen Harold - (harold@bcm.edu) |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | Henry Xie - (hxie1@bidmc.harvard.edu) |
| CIS Clinical Research Corporation Naperville, Illinois | |
| CIUSSS de l'Estrie - CHUS Saint-Jean-sur-Richelieu, Quebec | Marie-Claude Grenier - (marie-claude.grenier.ciussse-chus@ssss.gouv.qc.ca) |
| Cleveland Clinic Cleveland, Ohio | Raquel Rozich - (Rozichr@ccf.org) |
| Cleveland Clinic Florida Weston, Florida | Maria Gomez Mejia - (MEJIAGM@ccf.org) |
| Columbia University Medical Center/New York-Presbyterian Hospital (CUMC/NYPH) New York, New York | Alicha Daniel - (aad2223@cumc.columbia.edu) |
| Florida Heart and Vascular, LLC dba Florida Heart Rhythm Specialist, PLLC South Pasadena, Florida | Adryanna Alban - (adryanna.alban@flahrs.com) |
| Geisinger Commonwealth School of Medicine Scranton, Pennsylvania | |
| HMH Hospitals Corporation Hackensack, New Jersey | Stephanie Lynes - (stephanie.lynes@hmhn.org) |
| Hamilton Health Sciences (HHS) Hamilton, Ontario | Kiran Qamar - (qamarulisl@HHSC.CA) |
| Hartford Hospital Hartford, Connecticut | Saskia Campbell - (Saskia.Campbell@hhchealth.org) |
| Heart Rhythm Solutions Davie, Florida | Daniela Rodriguez - (Daniela@heartrhythmsolutions.com) |
| Icahn School of Medicine at Mount Sinai New York, New York | Ugur Gurol - (Ugur.Gurol@mountsinai.org) |
| Inova Heart and Vascular Institute Falls Church, Virginia | Tracy Plummer - (tracy.plummer@inova.org) |
| Lehigh Valley Hospital Inc. Allentown, Pennsylvania | Traci L Eichelberger - (Traci.Eichelberger@jefferson.edu) |
| Lovelace Medical Center Albuquerque, New Mexico | |
| MH Mission Hospital LLLP- Asheville Cardiology Associates Asheville, North Carolina | Olivia Lim - (olivia.lim@hcahealthcare.com) |
| Massachusetts General Hospital Boston, Massachusetts | Chris Azzam - (cazzam@MGH.HARVARD.EDU) |
| Mayo Clinic Rochester, Minnesota | Axe M Ahmed - (Ahmed.Abdimajid@mayo.edu) |
| Mazankowski Alberta Heart Institute/University of Alberta Edmonton, Alberta | Lee-Ann Langkaas - (Lee-Ann.Langkaas@albertahealthservices.ca) |
| Medical University of South Carolina (MUSC) Charleston, South Carolina | Olivia Washington - (washoliv@musc.edu) |
| Mercy Gilbert & Chandler Regional Medical Centers, Gilbert AZ Gilbert, Arizona | Jacqueline Killian - (jacqueline.killian@commonspirit.org) |
| Montreal Heart Institute Montreal, Quebec | François François - (Francois.Lemarbre@icm-mhi.org) |
| Mount Sinai Medical Center of Florida, Inc. Miami Beach, Florida | Giselle Cortez - (Giselle.CortezVargas@msmc.com) |
| Newark Beth Israel Medical Center Newark, New Jersey | Patricia Policastro - (Patricia.Policastro@rwjbh.org) |
| Newmarket Electrophysiology Research Group Inc. (NERG) Newmarket, Ontario | Lynn Nyman - (lnyman@southlake.ca) |
| Northwestern University Chicago, Illinois | Katrina Martin - (katrina.martin@nm.org) |
| Nova Scotia Health Authority Halifax, Nova Scotia | Stephanie Hobbs - (Stephanie.hobbs@nshealth.ca) |
| Novant Health Winston-Salem, North Carolina | |
| Oregon Health & Science University Portland, Oregon | Liz Cannard - (cannarde@ohsu.edu) |
| Penn Medicine Lancaster General Lancaster, Pennsylvania | Andrew Hershey - (Andrew.Hershey@pennmedicine.upenn.edu) |
| Prisma Health-Upstate Greenville, South Carolina | Prisma Health-Upstate Shrum - (ann.shrum@prismahealth.org) |
| Research Institute of the McGill University Health Centre (RI-MUHC) - MUHC, Montreal General Hospital Montreal, | |
| Rush University Chicago, Illinois | |
| Sentara Healthcare Newport News, Virginia | |
| South Denver Cardiology Associates Littleton, Colorado | Kathrin Siegel - (ksiegel@southdenver.com) |
| St. Luke's University Health Network Easton, Pennsylvania | Kyle McFadden - (Kyle.McFadden@sluhn.org) |
| St. Mark's Hospital Salt Lake City, Utah | Pragyna Gundaboina - (Pragyna.Gundaboina@HCAhealthcare.com) |
| Sunnybrook Research Institute Toronto, Ontario | Ambreen Syeda - (ambreen.syeda@sunnybrook.ca) |
| Texas Health Research & Education Institute Arlington, Texas | Rebecca Wade - (rebeccawade@texashealth.org) |
| The Christ Hospital Cincinnati, Ohio | Susanne Pasley - (Susanne.Pasley@thechristhospital.com) |
| The MetroHealth System Cleveland, Ohio | Pete Leo - (pleo@metrohealth.org) |
| The Valley Hospital, Inc. Paramus, New Jersey | Lauren Tedeschi - (ltedesc2@Valleyhealth.com) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | |
| Trustees of Indiana University Indianapolis, Indiana | Molly Stearns - (mstearns2@IUHEALTH.ORG) |
| University of Arizona College of Medicine- Phoenix Tucson, Arizona | Raeven Maxwell - (Raeven.Maxwell@bannerhealth.com) |
| University of Arkansas for Medical Sciences (UAMS) Little Rock, Arkansas | Urvashi Kalola - (ukalola@uams.edu) |
| University of British Columbia Vancouver, British Columbia | Munyura Yannick - (yannick.munyura@ubc.ca) |
| University of Calgary Calgary, Alberta | |
| University of California San Diego San Diego, California | Jesus Gil - (jegil@health.ucsd.edu) |
| University of Chicago Chicago, Illinois | |
| University of Colorado (Anschutz Medical Campus) Denver, Colorado | Tanner Bloks - (tanner.bloks@cuanschutz.edu) |
| University of Florida Jacksonville Jacksonville, Florida | Latonya Been - (latonya.been@ufhealth.org) |
| University of North Carolina Chapel Hill, North Carolina | Elias Wen - (emwen@email.unc.edu) |
| University of Ottawa Heart Institute Ottawa, Ontario | Maitreya PATEL - (MaPatel@ottawaheart.ca) |
| University of Pennsylvania Philadelphia, Pennsylvania | Mary Gnap - (Mary.Gnap@pennmedicine.upenn.edu) |
| University of Pittsburg Pittsburgh, Pennsylvania | Sherry Pellegrino - (pellegrinosl@upmc.edu) |
| University of South Florida Tampa, Florida | Jacky He - (jackyhe@usf.edu) |
| University of Vermont Colchester, Vermont | Sonja Baden - (Sonja.Baden@uvmhealth.org) |
| University of Virginia Health System Charlottesville, Virginia | |
| University of Washington Seattle, Washington | Adele Stefanowicz - (amstef99@uw.edu) |
| Université Laval Québec, | Marina Sanchez - (marina.sanchez.1@ulaval.ca) |
| Victoria Cardiac Arrhythmia Trials (VCAT) Inc. Victoria, British Columbia | Matthew Coxon - (mcoxon@catrials.org) |
| Virginia Commonwealth University Richmond, Virginia | |
| Virtua Health Camden, New Jersey | Marisa Brown - (Mbrown3@virtua.org) |
| Waterloo Wellington Cardiovascular Research Institute (WWCRI) - St. Mary's General Hospital Kitchener, | |
| Weill Cornell Medicine New York, New York | Penn Collins - (gpc4001@med.cornell.edu) |
| Yale University New Haven, Connecticut | Meg Leiss - (Margaret.leiss@yale.edu) |
ULTRA-HFIB-Redo: Ultrasound-based Renal Sympathetic Denervation Vs Control in Redo Ablation Patients
Jeff Lam, MS - jeff.lam@mountsinai.org
NCT05988411
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Age ≥ 18;
* Planned for a redo AF ablation procedure (paroxysmal or persistent); (prior to randomization, a technically successful AF ablation procedure, defined as successful pulmonary vein isolation, if needed, as well as bidirectional block of any attempted anatomic lesion sets such as cavotricuspid isthmus line, roofline, mitral line and superior vena cava isolation, must have been completed). Note: the clinical recurrences must primarily be atrial fibrillation, and not atrial flutter/tachycardia (that is, a prospective patient may have a AFL/AT recurrences, but AF must be the dominant recurrent rhythm.)
* History of hypertension and either:
* Documented history of SBP≥160 or DBP≥100, or;
* Receiving ≥1 antihypertensive medication;
* Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
Exclusion Criteria:
* Long-standing persistent AF (\>12 months); \>3 prior atrial fibrillation ablations (lifetime); AF ablation within 3 months of enrollment; extensive scar in left atrium.
* Individual with valvular AF or AF due to a reversible cause
* Prior treatment with other devices for hypertension including but not limited to ROX Coupler, Mobius stent, and/or the CVRx barostimulator device.
* NYHA class IV congestive heart failure;
* Individual has renal artery anatomy that is ineligible for treatment (as determined by renal angiography);
* Main renal artery diameter \<3mm or \>8.0 mm
* Main renal treatable artery length \< 20 mm (length may include proximal branches)
* Presence of renal artery stenosis of any origin ≥30%
* Calcification in renal arteries
* Prior renal denervation procedure
* Presence of abnormal kidney tumors
* Renal artery aneurysm
* Pre-existing renal stent or history of renal artery angioplasty
* Pre-existing aortic stent or history of aortic aneurysm
* Fibromuscular disease of the renal arteries
* Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter
* Individual has an estimated glomerular filtration rate (eGFR) of less than 40mL/min/1.73m2, using the MDRD calculation;
* Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)
* Individual with known allergy to contrast medium not amendable to treatment.
* Life expectancy \<1 year for any medical condition
* Individual has experienced a myocardial infarction, unstable angina, cerebrovascular accident, or heart failure admission within 3 months of the baseline visit.
* Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis.
* Female participants who are pregnant or nursing.
* Individual has known secondary hypertension.
* Individual has a single functioning kidney (either congenitally or iatrogenically).
* Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
* Patients concurrently enrolled in any other investigational drug or device trial that would interfere with the conduction of this protocol. DEVICE: Renal Denervation, DEVICE: Catheter Ablation
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
I'm interested
Share via email
Show 8 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Arrhythmia Research Group Jonesboro, Arkansas | Sarah Owens - (sowens@dnairresearch.com) |
| Christus Tyler, Texas | Adrian Maples - (adrian.maples@christushealth.org) |
| Henry Ford Health System Jackson, Michigan | Danielle Delmotte - (ddelmot2@hfhs.org) |
| Los Robles Medical Center Thousand Oaks, California | Marya Bengali - (Marya.Bengali@HCAhealthcare.com) |
| Mount Sinai Hospital New York, New York | Jeff Lam, MS - (jeff.lam@mountsinai.org) Betsy Ellsworth, MSN ANP - (betsy.ellsworth@mountsinai.org) |
| Trident Medical Center Charleston, South Carolina | Molly Harper - (Molly.Harper@hcahealthcare.com) |
| UCSF San Francisco, California | Marialena Varympopioti - (MariaEleni.Varympopioti@ucsf.edu) |
| Virginia Commonwealth University Richmond, Virginia | Caleb Bridgwater - (Caleb.Bridgwater@vcuhealth.org) |
Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator (CARVTOP-ICD)
Mehmet Aktas, M.D. - Mehmet_Aktas@URMC.Rochester.edu
NCT06964464
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
* Age ≥ 18 years
* ICD implanted for primary prevention for HFrEF (either ICM or NICM) with remote monitoring capability
* Current treatment with metoprolol succinate and willing to switch to carvedilol
* LVEF \<50% during the past 12 months prior to consent
Exclusion Criteria:
* Unwilling or unable to follow the protocol
* Treatment with any other ßB than metoprolol succinate or no ßB treatment
* Known prior intolerance or contraindication to carvedilol
* Systolic blood pressure \<100 mmHg
* Enrollment in another clinical trial
* Inability or unwilling to consent DRUG: Metoprolol Succinate, DRUG: Carvedilol
Heart Failure With Reduced Ejection Fraction (HFrEF), Sudden Cardiac Death, Ventricular Arrhythmia, Implantable Cardioverter Defibrillator (ICD), Beta-blocker Therapy, Cardiomyopathy
arrhythmia, heart failure, ICD, implantable cardioverter defibrillator, ICD shock, carvedilol, metoprolol succinate, beta-blocker
I'm interested
Share via email
Show 13 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| AdventHealth Redmond Rome, Georgia | Charles Jackson, MD - (charles.jackson.md@adventhealth.com) Kathy Jones - (kathy.d.jones@adventhealth.com) |
| AdventHealth Shawnee Mission Shawnee Mission, Kansas | Obadah Al Chekakie, MD - (MObadah.AlChekakie.MD@AdventHealth.com) Megan Kelly - (Megan.Kelly1@adventhealth.com) |
| Christus Trinity Mother Frances Health System Tyler, Texas | Joshua Rutland, MD - (joshua.rutland@christushealth.org) Carol Cushman - (carol.cushman@christushealth.org) |
| Creighton University Medical Center Omaha, Nebraska | Attila Roka, MD - (attilaroka@creighton.edu) Lois A. Rasmussen - (lois.rasmussen@commonspirit.org) |
| Health University of Utah Salt Lake City, Utah | Ravi Ranjan, MD - (ravi.ranjan@hsc.utah.edu) Audra Eaquinto - (audra.eaquinto@hsc.utah.edu) |
| Henry Ford Health System Jackson, Michigan | Waddah Maskoun, MD - (wmaskou1@hfhs.org) Briita Wanhala - (bwanhal1@hfhs.org) |
| HonorHealth Scottsdale, Arizona | Geoffrey Jao, MD - (gjao@honorhealth.com) Mary Futch Moyer - (mfutch@honorhealth.com) |
| New York-Presbyterian Brooklyn Methodist Hospital Brooklyn, New York | Gioia Turitto, MD - (git9006@nyp.org) Shana Hayes, M.S. - (cmc9055@nyp.org) |
| SUNY Downstate Brooklyn, New York | Adam S Budzikowski, MD - (abudzikowski@downstate.edu) Ann Harris - (ann.harris@downstate.edu) |
| University of Mossouri Columbia, Missouri | Brian Bostick, MD - (bostickb@health.missouri.edu) Charles Donigian - (donigianc@health.missouri.edu) |
| University of Rochester Medical Center Rochester, New York | Amole Ojo, MD - (amole_ojo@urmc.rochester.edu) Samantha Delmartino - (samantha_delmartino@urmc.rochester.edu) |
| University of Wisconsin Hospital and Clinics Madison, Wisconsin | Ryan Kipp, MD - (rtkipp@medicine.wisc.edu) Karen Olson - (kjolson@medicine.wisc.edu) |
| Virginia Commonwealth University Richmond, Virginia | Keyur Shah, MD - (keyur.shah@vcuhealth.org) Anna Baranova - (anna.baranova2@vcuhealth.org) |
Acoramidis Transthyretin Amyloidosis Prevention Trial in the Young (ACT-EARLY) Study in Asymptomatic Carriers of a Pathogenic TTR Variant
Medical Information - medinfo@eidostx.com
NCT06563895
Show full eligibility criteria
Hide eligibility criteria
Key
Inclusion Criteria:
* Male or female ≥ 18 to ≤ 75 years of age inclusive.
* Participants must have an established genotype (hetero- or homozygosity) of a TTR gene variant that is known to be pathogenic (eg, V30M/p.V50M, V122I/p.V142I, T60A/p.T80A, or any other pathogenic TTR variant(s)) confirmed by central laboratory prior to randomization.
* Participant's age is no more than 10 years (≤ 10) younger than the PADO.
Key Exclusion Criteria:
* Evidence of ATTR-CM or ATTR-PN.
* Presence of a TTR variant known to be phenotypically protective (eg, T119M, R104H).
* Current or past treatment with other TTR modifying therapies.
* Contraindication to or inability to undergo Cardiac magnetic resonance testing.
* Major organ dysfunction, including: kidney disease, liver disease, heart disease (including cardiomyopathy), neuropathy
* Other diseases or conditions such has cancer within 3 years, untreated hyperthyroidism or hypothyroidism, type 1 diabetes, active hepatitis B or C, HIV.
* Major surgery within the past 3 months or planned during the next 12 months.
* Known hypersensitivity to acoramidis. DRUG: Acoramidis, DRUG: Placebo oral tablet
Amyloidosis, Amyloid Cardiomyopathy, Transthyretin Amyloidosis, Cardiomyopathies, Heart Diseases, Polyneuropathies
Amyloidosis, ATTR-CM, ATTR-PN, Transthyretin, Amyloid, TTR
I'm interested
Share via email
Show 64 locations
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| AP-HP Hopital Bicetre Le Kremlin-Bicêtre, | |
| AP-HP Hopital Henri Mondor Créteil, | |
| Azienda Ospedaliero-Universitaria Careggi Florence, | |
| Azienda Ospedaliero-Universitaria Sant'Andrea Rome, | |
| Azienda Ospedaliero-Universitaria di Bologna IRCCS Policlinico di S.Orsola Bologna, | |
| Brigham and Women's Hospital Boston, Massachusetts | |
| CHU de Toulouse - Hopital Rangueil Toulouse, | |
| Changhua Christian Hospital - Taiwan Changhua, | |
| Charite Universitaetsmedizin Berlin Berlin, | |
| Chu Rennes Rennes, | |
| Columbia University Medical Center New York, New York | |
| Duke University Medical Center Durham, North Carolina | |
| Emory University School Of Medicine Atlanta, Georgia | |
| Fondazione IRCCS Policlinico San Matteo Pavia, | |
| Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore Rome, | |
| Fondazione Toscana Gabriele Monasterio per la Ricerca Medica e di Sanità Pubblica - Ospedale San Cataldo Pisa, | |
| Henry Ford Health System Jackson, Michigan | |
| Hospital Clinico Universitario de Salamanca Salamanca, | |
| Hospital Universitari de Bellvitge Barcelona, | |
| Hospital Universitario Juan Ramon Jimenez Huelva, | |
| Hospital Universitario Puerta de Hierro Majadahonda, | |
| Hospital Universitario Son Llatzer Palma de Mallorca, | |
| Hvitfeldt Poulsen Aarhus, | |
| Inova Fairfax Hospital Falls Church, Virginia | |
| John H. Stroger, Jr. Hospital of Cook County Chicago, Illinois | |
| Johns Hopkins University Baltimore, Maryland | |
| Laurelton Heart Specialists Rosedale, New York | |
| Massachusetts General Hospital Boston, Massachusetts | |
| Mayo Clinic - Jacksonville Jacksonville, Florida | |
| Mayo Clinic - Rochester Rochester, Minnesota | |
| MedStar Washington Hospital Center - MedStar Heart and Vascular Institute Washington D.C., District of Columbia | |
| Medical University of South Carolina (MUSC) Charleston, South Carolina | |
| Mount Sinai Hospital New York, New York | |
| National Neuromuscular Research Institute Austin, Texas | |
| New York University (NYU) School of Medicine - Langone Medical Center New York, New York | |
| Oregon Health & Science University Portland, Oregon | |
| Prisma Health Cancer Institute Greenville, South Carolina | |
| Rutgers-Robert Wood Johnson Medical School New Brunswick, New Jersey | |
| Samsung Medical Center Seoul, | |
| Seoul National University Hospital Seoul, | |
| Seoul St. Mary's Hospital Seoul, | |
| Severance Hospital, Yonsei University Health System Seoul, | |
| Singapore General Hospital Singapore, | |
| St. Luke's Hospital of Kansas City Kansas City, Missouri | |
| Stanford University Palo Alto, California | |
| Taipei Veterans General Hospital Taipei, | |
| Tallaght University Hospital - The Adelaide and Meath Hospital Dublin, | |
| Unidade Local de Saude de Santa Maria EPE - Hospital de Santa Maria Lisbon, | |
| Unidade Local de Saude de Santo Antonio EPE - Hospital de Santo Antonio Porto, | |
| Universitair Medisch Centrum Utrecht Utrecht, | |
| University College London Hospitals NHS Foundation Trust London, | |
| University Malaya Medical Centre (UMMC) Kuala Lumpur, | |
| University Medical Center Groningen Groningen, | |
| University of British Columbia Vancouver, British Columbia | |
| University of Calgary Calgary, Alberta | |
| University of California, Los Angeles (UCLA) - David Geffen School of Medicine Los Angeles, California | |
| University of California, San Diego (UCSD) - Medical Center La Jolla, California | |
| University of California, San Francisco (UCSF) San Francisco, California | |
| University of Colorado Anschutz Aurora, Colorado | |
| University of Maryland Medical Center Baltimore, Maryland | |
| University of Utah Salt Lake City, Utah | |
| Virginia Commonwealth University Richmond, Virginia | |
| Washington University in St. Louis St Louis, Missouri | |
| Yale University School of Medicine - Section of Cardiology New Haven, Connecticut |