CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 451 enrolled
Drug / intervention
HeartWare® VAS +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/NCT01166347
NCT01166347N/ACompleted
CompareCT.gov

A Prospective, Randomized, Controlled, Un-blinded, Multi-Center Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System (VAS) for Destination Therapy of Advanced Heart Failure

Medtronic Cardiac Rhythm and Heart Failure·interventional·Posted Jul 21, 2010·Updated Sep 6, 2018

In Brief

A clinical study evaluating HeartWare® VAS and Control LVAD for Chronic Heart Failure. Completed, enrolled 451 participants across 48 sites.

Detailed Summary

The purpose of this study is to determine the safety and effectiveness of the HeartWare Ventricular Assist System in patients with chronic Stage D/ New York Heart Association (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
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 21, 2010
Enrollment StartAug 1, 2010
Primary CompletionMay 1, 2014
Study CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 15.9 years ago

Interventions

HeartWare® VASdevice

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.