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