The purpose of this study is to evaluate an electrically powered, totally implantable left ventricular assist system (LVAS) in patients with severe, chronic congestive heart failure. The device will be supplied by the Production Center (separate National Heart, Lung, and Blood Institute (NHLBI) contract) to two clinical centers for implantation and evaluation according to common approved protocols developed by the investigators in the program. This contract will support and coordinate the activities of the two clinical centers. The contractor will be responsible for collecting and evaluating data generated by the clinical centers. The contractor will be responsible for coordinating protocol design and receiving, editing, storing, and analyzing data acquired by the clinical centers. It is expected that the contractor will assist in data preparation for the Investigational Device Exemption (IDE) processing with the FDA. The contractor will assist in modifying and refining clinical protocols and reports submitted by the clinical centers.
