A Prospective, Randomized, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of the HeartAssist 5® VAD System Compared to the Thoratec HeartMate II® VAD and HeartWare® HVAD for Left Ventricular Support in Patients Awaiting Cardiac Transplantation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- ReliantHeart Inc.
- Enrollment
- 17
- Locations
- 14
- Primary Endpoint
- The primary endpoint is success at 180 days
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of the study is to evaluate the safety and effectiveness of the ReliantHeart HeartAssist 5® VAD System in patients listed for heart transplantation and at risk of death from refractory end-stage heart failure.
Detailed Description
The HeartAssist 5® VAD System is intended for use as a bridge to heart transplantation and will be compared to the HeartMate II and HVAD devices. Patients that meet the study criteria will be randomized 1:1 to either the HeartAssist 5® VAD System (treatment group) or control group (HeartMate II and HVAD). The physician will have the option to choose which control device to implant. The primary objective of the study is to show non-inferiority of the HeartAssist 5® (treatment group) to the control group.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Able to sign Informed Consent.
- •Body Surface Area (BSA) ≥ 1.2 m
- •Cardiac transplant candidate, defined as: Listed for cardiac transplant, and designated by the institution's multidisciplinary transplant committee as appropriate forLVAD Bridge-to-Transplantation therapy, or Designated by the institutions's multidisciplinary transplant committee as: 1) an appropriate candidate for LVAD Bridge-to transplant therapy, and 2) An inappropriate candidate for LVAD destination therapy
- •LVAD implantation has been approved by the institution's multidisciplinary transplant committee.
- •Patient is NYHA Class IV.
- •Able to return to the clinical site for all routine follow up visits.
Exclusion Criteria
- •Cardiothoracic surgery within 30 days prior to enrollment.
- •Acute Myocardial Infarction within 14 days prior to enrollment.
- •Prior cardiac transplantation, left ventricular reduction surgery, cardiomyoplasty or left ventricular assist device.
- •Mechanical, animal, or human tissue heart valve.
- •History of untreated abdominal or thoracic aortic aneurysm \> 5 cm.
- •On ventilator support for \> 72 hours within four days immediately prior to enrollment.
- •Ongoing mechanical circulatory support other than an intra-aortic balloon pump (IABP).
- •Proven history of pulmonary embolism within 90 days of enrollment.
- •Moderate to severe aortic insufficiency as determined by echocardiogram without plans for correction during pump implantation surgery.
- •Requires aortic, mitral, tricuspid or pulmonary valve replacements (including Bioprosthetic valves) or left ventricular (LV) aneurysm resection.
Outcomes
Primary Outcomes
The primary endpoint is success at 180 days
Time Frame: 180 days
Success at 180 days is defined as alive on the original device, transplanted or explanted for heart recovery and alive 60 days after device explant.
Secondary Outcomes
- Adverse Events(180 days)
- Quality of Life(180 days)
- Functional Status(180 days)
- Neurologic Status(180 days)