NCT02205411

Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: ReliantHeart Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure
• Cardiac Failure
• Congestive Heart Failure
• Heart Failure, Left-sided

Interventions

Type	Name	Description
DEVICE	HeartAssist 5® VAD System	The HeartAssist 5® VAD System is a small, implantable pump that is designed to increase blood flow for patients who have heart failure. The device is intended to support patients in the hospital or at home.
DEVICE	Control VAD	The HeartMate II® VAD or HVAD®

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2014-07-31
• Last updated: 2018-07-18

Locations

14 sites across 1 country: United States