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

Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients

The purpose of this study is to evaluate and compare the effectiveness of the HeartMate II (HM II) Left Ventricular Assist Device (LVAD) support versus OMM in ambulatory NYHA Class IIIB/IV heart failure patients who are not dependent on intravenous inotropic support and who meet the FDA approved indications for HM II LVAD destination therapy.

The HeartMate II (HM II) LVAD is approved by the U.S. Food and Drug Administration (FDA) for use in destination therapy (DT) patients with New York Heart Association (NYHA) Class IIIB/IV symptoms.

The ROADMAP trial is a prospective, multi-center, non-randomized, controlled, observational study that is designed to evaluate the effectiveness of HM II LVAD support versus optimal medical management (OMM) in ambulatory NYHA Class IIIB/IV heart failure patients who are not dependent on intravenous inotropic support and who meet the FDA approved indications for HM II LVAD destination therapy. Subjects will be enrolled in one of two cohorts: OMM or LVAD. Together with the investigator, the subjects will decide which cohort to enter into at their baseline visit. This study will include experienced HM II LVAD implant centers as well as community centers that care for a large volume of heart failure patients. Study patients will be followed for up to 24 months post enrollment for survival, quality of life and functional status.

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