Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients
Overview
- Phase
- N/A
- Intervention
- HM II (HeartMate II LVAD)
- Conditions
- Heart Failure
- Sponsor
- Abbott Medical Devices
- Enrollment
- 200
- Locations
- 52
- Primary Endpoint
- Composite of survival with improvement in Six Minute Hallway Walk Test distance from baseline of ≥ 75m.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
HM II (HeartMate II LVAD)
Subjects who elect to, and receive HM II LVAD therapy at baseline
Intervention: HM II (HeartMate II LVAD)
OMM (Optimal Medical Management)
Subjects who elect to remain on optimal medical management
Intervention: OMM (Optimal Medical Management)
Outcomes
Primary Outcomes
Composite of survival with improvement in Six Minute Hallway Walk Test distance from baseline of ≥ 75m.
Time Frame: 12 months
Secondary Outcomes
- Risk stratified subgroup analysis of the primary endpoint and temporal analysis of primary endpoint.(6, 12, 18, and 24 months)
- Actuarial survival and survival free of stroke: a) intent-to-treat; and b) as treated.(24 months)
- Questionnaire on patient decisions related to LVAD therapy versus optimal medical management.(Baseline and 6, 12, 18 and 24 months)
- Accuracy of prognostic survival risk models including Seattle Heart Failure Model (SHFM) and HeartMate II Risk Score (HMRS)(Baseline and 6, 12, 18 and 24 months)
- Survival in LVAD group free of pump replacement.(24 months)
- Depression using Patient Health Questionnaire-9 (PHQ-9).(Baseline and 6, 12, 18 and 24 months)
- Functional status using 6MWT distance and NYHA Classification(Baseline and 6, 12, 18 and 24 months)
- Incidence of adverse events, rehospitalizations, days alive and not hospitalized.(3, 6, 9, 12, 15, 18, 21 and 24 months)
- Quality of Life using the EQ-5D-5L Health Utility Index.(Baseline and 6, 12, 18 and 24 months)