CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 494 enrolled
Drug / intervention
HeartWare® VAS (HVAD) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01966458
NCT01966458N/ACompleted
CompareCT.gov

A Prospective, Randomized, Controlled, Unblinded, Multi-Center Clinical Trial to Evaluate the HeartWare™ Ventricular Assist Device System for Destination Therapy of Advanced Heart Failure

Medtronic Cardiac Rhythm and Heart Failure·interventional·Posted Oct 21, 2013·Updated Oct 23, 2020

In Brief

A clinical study evaluating HeartWare® VAS (HVAD) and Control LVAD for Chronic Heart Failure. Completed, enrolled 494 participants across 47 sites.

Detailed Summary

This is a prospective, randomized, controlled, unblinded, multi-center evaluation of safety and efficacy in patients implanted with a HeartWare® HVAD who receive improved blood pressure management. Subjects have chronic Stage D or NYHA Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy, and who are ineligible for cardiac transplantation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Heart Failure
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 21, 2013
Enrollment StartOct 1, 2013
Primary CompletionAug 1, 2016
Study CompletionAug 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.7 years ago

Interventions

HeartWare® VAS (HVAD)device

The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.

Control LVADdevice

Any FDA-approved LVAD for destination therapy.