Heart Failure Clinical Trial
Official title:
Evaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study
This investigation will be conducted as an interventional intention-to-treat clinical study in a population of end stage heart failure patients who meet specific inclusion and exclusion criteria. The multi-center study will be prospective, dual-armed, non-blinded (open-label) and randomized, comparing a treatment group receiving the Jarvik 2000 LVAS with Post-Auricular Connector to an active control group treated with the PMA approved Thoratec HeartMate® II LVAS for Destination Therapy.
Study Success for Primary Endpoint A will be established if the proportion of subjects in the Treatment Group meeting the Subject Success Criteria A, is determined to be non-inferior to that of the Control Group (at two years) according to the pre-specified statistical analysis. Subject composite success requires the subject to achieve the Effectiveness Endpoint: 1. Two year actuarial survival 2. Freedom from procedures to repair, or replace the implanted device 3. Freedom from stroke resulting in a Modified Rankin Score of >3 at the two-year follow-up Study Success for Primary Endpoint B will be established if the proportion of subjects in the Treatment Group meeting the Subject Success Criteria B is determined to be superior to that of the Control Group (at three years) according to the pre-specified statistical analysis. Subject composite success requires the subject to achieve the Effectiveness Endpoint: 1. Three year survival 2. Freedom from the serious adverse event of drive cable or pump pocket infection ;
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