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

NCT02205411 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2018-07-18

No results posted yet for this study

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.

Conditions

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

Interventions

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®

Sponsors & Collaborators

  • ReliantHeart Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02205411 on ClinicalTrials.gov