Heart Failure Clinical Trial
Official title:
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
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.
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.
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