StudyFinder
SynCardia 70cc TAH-t for Destination Therapy (DT)
Recruiting
19 years and over
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
Judy Skroback, CIP, CRCP - jskroback@syncardia.com
Medalion, Benjamin
N/A
HM20004553
NCT02232659
See this study on ClinicalTrials.gov