Search Results
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial (CLASP II TR)
Edwards TMTT Clinical Affairs - TMTT_Clinical@edwards.com
• Would prevent proper TR reduction due to interaction of the lead with the leaflets
• Were implanted in the RV within the last 90 days prior to the point of enrollment * Primary non-degenerative tricuspid disease * Previous tricuspid valve repair or replacement that would interfere with placement of PASCAL * Clinically significant, untreated coronary artery disease requiring revascularization, unstable angina, evidence of acute coronary syndrome, recent myocardial infarction * Significant intra-cardiac mass, thrombus, or vegetation per echo core lab assessment * Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 90 days * Recent Stroke * Active gastrointestinal (GI) bleeding * Presence of infiltrative cardiomyopathy or valvulopathy (including carcinoid, amyloidosis, sarcoidosis, hemochromatosis) or significant congenital heart disease, including but not limited to atrial septal defect, RV dysplasia, and arrhythmogenic RV * Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365 days), or any planned percutaneous cardiac procedure within the next 90 days * Any of the following cardiovascular procedures:
• Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days prior to the point of enrollment
• Carotid surgery within 30 days prior to the point of enrollment
• Direct current cardioversion within the last 30 days prior to the point of enrollment
• Leadless RV pacemaker implant within the last 30 days prior to the point of enrollment
• Cardiac surgery within 90 days prior to the point of enrollment * Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation * Known history of untreated severe symptomatic carotid stenosis or asymptomatic carotid stenosis * Active endocarditis within the last 90 days or infection requiring antibiotic therapy within the last 14 days * Patient is oxygen-dependent or requires continuous home oxygen * Pregnant, breastfeeding, or planning pregnancy within the next 12 months (365 days) * Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator * Patient is currently participating in another investigational biologic, drug, or device clinical study * Patient has other medical, social, or psychological conditions that preclude appropriate consent and follow-up, or the patient is under guardianship * Any patient considered to be vulnerable
Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment (CRT-DRIVE)
Claudia M Amatruda, PhD - amatruda@xspline.com
• Appropriately signed and dated informed consent.
• Age ≥18 years at time of consent.
• CRT indication according to the 2021 ESC guidelines on cardiac pacing and CRT (class I and IIA indication in patients with LBBB QRS morphology) or to 2017 AHA/ACC/HFSA guidelines (COR I).
• Sinus rhythm
• QRS duration ≥130 ms
• Left bundle branch block
• Left ventricular ejection fraction ≤35%
• Symptomatic heart failure NYHA class ≥ II
• Documented stable medical treatment for at least 6 months
• No cardiovascular intervention during the last 6 month Exclusion Criteria are:
• History of persistent or permanent atrial fibrillation
• Previous pacemaker or ICD implantation
• Indication to pacing due to bradycardia
• Patients considered for His bundle pacing or cardiac conduction pacing
• Patients with unstable angina
• Subject experienced a recent myocardial infarction, within 40 days prior to enrollment
• Subject underwent coronary artery bypass graft or valve surgery, within 90 days prior to enrollment
• Subject is post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year
• Subject is implanted with a left ventricular assist device
• Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure
• Subject has severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated within study period)
• Subject has congenital heart disease
• Subject has a mechanical right-sided heart valve
• Subject has a life expectancy of less than one year in the opinion of the investigator
• Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
• Subject is enrolled in one or more concurrent studies that would confound the results of this study
• Patients who have contraindications to CT scanning.
• Patients with chronic kidney diseases and estimated glomerular filtration rate (eGMR) calculated based on CKD-EPI 2009 < 40 ml/min/1.73m2
Quality of Pediatric Resuscitation in a Multicenter Collaborative (pediRES-Q)
Vinay Nadkarni, MD, MS - nadkarni@chop.edu
Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
Gwaltney, Lindsey - lbgwaltney@vcu.edu
International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors (i-RECORd)
Marco Carini, Prof. - carini@unifi.it
• Radiological diagnosis of renal tumor susceptible to active treatment or AS/WW.
• Age ?18 years
• Informed consent signed
• Patient refuse to participate in clinical research.
• Urothelial renal carcinoma.
Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer
Iovance Biotherapeutics Study Team lungcelltherapy.com - Clinical.Inquiries@iovance.com
Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant
Sherry Boyett, RN - sherry.boyett@vcuhealth.org
Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia (SCIMS Main)
Ashraf Gorgey, MPT, PhD, FACSM, FACRM - Ashraf.Gorgey@va.gov
• A written clearance from the study medical doctor to ensure that the participant is safely able to engage in the study.
• Participants must have a companion that will be able to help him/her throughout the study.
• Greater than 1-year post SCI, neurologic level of C8 or above.
• American Spinal Injury Association Impairment Scale (AIS) scores of B, C, or D indicating presence of an incomplete SCI.
• Visible muscle contraction response to NMES wrist extensors, bilaterally.
• Agreement to use telehealth services for delivery of research exercise training by study staff. Possesses appropriate technology to engage in telehealth including a personal web camera, computer, microphone, speakers, and high-speed broadband internet connection, valid email address (needed to obtain VA issued video conferencing software), and telephone number used to obtain login credentials for the In-Home Video Software - Cisco Jabber Video for Telepresence Software.
• Response of muscle contraction of wrist extensors bilaterally to neuromuscular electrical stimulation.
• Unhealed fracture in upper or lower extremities.
• Severe scoliosis, severe upper extremity contractures, or other musculoskeletal issues that would impede participation in a BES + TS intervention or valid evaluation of outcome measures.
• High resting blood pressure greater than 140/80 mmHg.
• Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons.
• Pregnancy (female participants). A home pregnancy test will be conducted to role out any pregnancy before the study at the McGuire VAMC. The test will be repeated every month during the course of the study.
• Implanted pacemakers and/or implanted defibrillator devices.
• Other exclusion criteria may include the presence of implanted electrical device, cancer, thrombosis, pacemaker, defibrillator, or seizures. Patients who are currently on or receive anti-platelet or anticoagulant medications will be excluded from the trial.
• Any condition that, in the judgment of the principal investigator or medical provider, precludes safe participation in the study.
• Other exclusion criteria at the discretion of the medical team may include:
• Uncontrolled autonomic dysreflexia (AD), refers to episodes of AD that do not respond to medications to ensure stable blood pressure in persons with SCI
• Concurrent severe neurological injuries other than SCI: MS, CP, severe TBI, and stroke.
• Unresolved deep vein thrombosis.
• Psychiatric or cognitive impairments that preclude adherence to the intervention.
• Known cardiac pathology that precludes safe participation.
• Metabolic conditions such as cardiovascular disease, uncontrolled type II diabetes mellitus, uncontrolled hypertension, and those on insulin.
• Presence of pressure sores stage three or greater.
• Presence of a symptomatic urinary tract infection.
• Severe spasticity as assessed by the Modified Ashworth Scale.
• Changing neurologic status due to conditions such as progressive posttraumatic syringomyelia.
Children's Bipolar Network Treatment Trial I (CBN)
David J Miklowitz, PhD - dmiklowitz@mednet.ucla.edu
GiST (GiST)
Vences, Karina - venceskm@vcu.edu
Uptake of NCI Research Tested Intervention Program to Increase CRC Screening in Rural Setting
Preston, Michael - prestonm2@vcu.edu
Community Outreach and Engagement Key Informant Interviews
Cummings, Yvonne - yvonne.cummings@vcuhealth.org
A Cognitive Task Analysis of Pediatric Hematology/Oncology Faculty
DiazGranados, Deborah - diazgranados@vcu.edu
CASTOR-2: Identifying Subclinical Cardiotoxicity Following RT for Locally Advanced Lung Cancer (CASTOR-2)
Kontos, Emily - kontosej@vcu.edu
Killer Immunoglobulin-Like Receptor Interactions to Optimize Natural Killer Cell Function in SCT
Roberts, Catherine, H. - croberts2@vcu.edu
Biomarkers of Malignant and Non-Malignant Pleural Effusion
Narron, Kyle, A - Kyle.Narron@vcuhealth.org
Unpacking Multilevel Drivers of Cardiotoxicity Disparities in Breast Cancer Survivors
Sutton, Arnethea - abrahamal@vcu.edu
Cognitive Support Technology for Postsecondary Students with Traumatic Brain Injuries
Getzel, Elizabeth, E - lgetzel@vcu.edu
Prognostic Gene Expression Profiling and Adjuv Therapy in Stage IIB-C & IIIA-B Cutaneous Melanoma
Gnanasigamani Manogaram, Merlin Margaret - gnanasigamam@vcu.edu
Feasibility, Acceptability, and Preliminary Effectiveness of the ICAN QUIT Tobacco Program at VCUH
Hunley, Rachel - rachel.hunley@vcuhealth.org
Assessing Electronic Cigarette Nicotine Flux (Project 2 Flux Study)
ctrrecruit@vcu.edu
Longitudinal Survey and Behavior Assessment of Experienced E-cigarette Users (P4 @ VCU)
ctrrecruit@vcu.edu
Salad Bars in the National School Lunch Program
ctrrecruit@vcu.edu
Predicting Effects of Tobacco Product Flavor Regs Among Black/African American Menthol Smokers
ctrrecruit@vcu.edu
Effects of E-Cigarette Nicotine Delivery on Abuse Liability in Smokers
ctrrecruit@vcu.edu
Noninvasive Assessment of Esophageal Varices in Patients with Unresectable Hepatocellular Carcinoma
ctrrecruit@vcu.edu
Pt QoL & Social Support after Cytoreductive Surgery & Hyperthermic Intraperitoneal Chemo
Freudenberger, Devon - devon.freudenberger@vcuhealth.org
Role of GABA in Motor Symptoms and Neurophysiological Abnormalities in Dystonia
Crump, Elizabeth - crumpeg@vcu.edu
Cancer Prevention for Virginia Firefighters
ctrrecruit@vcu.edu