HeartWare® Endurance Trial

Full Title

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

Purpose of Study

The purpose of this study is to determine the safety and effectiveness of a left ventricular assist device (LVAD), the HeartWare® VAS, in treating the condition of chronic heart failure.  There are two LVADs in this study:

  • the HeartWare® VAS which is investigational, meaning that it is not approved by the U.S. Food and Drug Administration (FDA), and
  • the HeartMate II® Left Ventricular Assist Device (LVAD) which has been approved by the FDA for use in patients who cannot receive a heart transplant (Destination Therapy) as well as patients waiting for a transplant (Bridge to Transplant). 

The HeartWare® VAS is approved in Europe only for patients awaiting a transplant.  Patients will be randomly assigned (by chance alone) to receive either the investigational HeartWare® VAS device or the FDA approved HeartMate II® Left Ventricular Assist Device (LVAD).

Sponsor: HeartWare, Inc.

Local Principal Investigator: Robert L. Kormos, MD, FAHA, FRCS(C)

Division(s)

Research Type

Contact Information

Chrissy Butler, RN
412-647-2782
butlercm@upmc.edu

Eligibility

Patients with advanced heart failure that are not responding well to current treatment, and because they are not a candidate for a heart transplant.

For more information, visit the ClinicalTrials.gov link.