A Prospective, Randomized, Controlled, Un-blinded, Multi-Center Clinical Trial to Evaluate the HeartWare(RegisteredTM) Ventricular Assist System for Destination Therapy of Advanced Heart Failure
- Clements University Hospital
Matthias Peltz, M.D.
This is a prospective, randomized, unblinded, multi-center, non-inferiority evaluation of the HeartWare[RegisteredTM] VaS versus a control group consisting of any FDa-approved LVaD approved for destination therapy. Patients are randomized to HeartWare[RegisteredTM] VaS or control LVaD in a 2:1 ratio. each patient receiving the HeartWare[RegisteredTM] VaS or control LVaD is followed to the primary endpoint at 2 years, with a subsequent follow-up period extending to 5 years post implant.
1. Must be >=18 years of age at consent
2. Body Surface Area (BSA) >= 1.2 m2
3. 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
4. Left ventricular ejection fraction < 25%
5. LVAD implant is intended as destination therapy
6. Must be able to receive either the HeartWare(RegisteredTM) VAS or control LVAD
7. Female patients of childbearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives or a combination of condom and spermicide) for the duration of the study.
8. The patient or legally authorized representative has signed the informed consent form