Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device (LVAD) and Medical Management

The following are general criteria; more specific criteria are included in the study protocol: Inclusion Criteria: * NYHA Class IIIB/IV (refer to Appendix IV for definitions) * Left ventricular ejection fraction (LVEF) ≤ 25% * Not currently listed for heart transplantation, and not planned in next 12 months * On optimal medical management * Limited functional status as demonstrated by 6MWT \<300 meters * At least: * One hospitalization for HF in last 12 months or * At least 2 unscheduled emergency room or infusion clinic visits (may include intravenous diuretic therapy, etc.) for HF in last 12 months Exclusion Criteria: * Presence of mechanical aortic or mitral valve, including planned conversion to bioprosthesis * Platelet count \< 100,000/mi within 48 prior to enrollment * Any inotrope use within 30 days prior to enrollment * Inability to perform 6MWT for any reason * Any condition, other than heart failure, that could limit survival to less than 2 years * History of cardiac or other organ transplant * Existence of any ongoing mechanical circulatory support (including intraaortic balloon pump, temporary circulatory support devices, etc.) at the time of enrollment * Presence of active, uncontrolled, systemic infection * History of an unresolved stroke within 90 days prior to enrollment, or a history of cerebral vascular disease with significant (\> 80%)extracranial stenosis * Contraindication to anticoagulation/antiplatelet therapy * CRT or CRT-D within 3 months prior to enrollment * Coronary revascularization (e.g. CABG, PCI) within 3 months prior to enrollment