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)


Research Type

Contact Information

Chrissy Butler, RN


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.