A Clinical Trial to Evaluate the HeartWare Ventricular Assist System (ENDURANCE) - Destination Therapy
Status: Open to Enrollment
Start Date: Aug 01 2010
End Date: OPEN
The HeartWare® VAS is a small, implantable centrifugal pump that was designed to provide flows up to 10 L/min and is surgically placed against the left side of the heart delivering blood from the heart to the rest of the body. Due to its small size and mechanical simplicity, the HeartWare® Ventricular Assist System may provide benefits not currently available with existing technology. The HeartWare VAS is being evaluated for safety and effectiveness in patients with end-stage heart failure who are ineligible for heart transplantation and thus will have the device for Destination Therapy or life-therapy. The primary endpoint of the trial is stroke-free survival to 2 year with other outcomes including quality of life, functional status improvement, and freedom from adverse events.
- Must be 18 years of age or older at consent
- Body Surface Area (BSA) equal or greater than 1.2 m2
- Patients with advanced heart failure symptoms (Class IIIB or IV) who are: (patient must meet one of the following)
a) On optimal medical management, including dietary salt restriction and diuretics, for at least 45 out of the last 60 days and are failing to respond; or
b) In Class III or Class IV heart failure for at least 14 days, and dependent on intra aortic balloon pump (IABP) for 7 days and/or inotropes for at least 14 days
- Left ventricular ejection fraction < 25%
- LVAD implant is intended as destination therapy
- Must be able to receive either the HeartWare® VAS or control LVAD
- Female patients of childbearing potential must agree to use adequate contraceptive precautions for the duration of the study.
- The patient or legally authorized representative has signed the informed consent form
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