HeartWare® Endurance Trial
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)
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.