Heart Failure Clinical Trial
Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device (LVAD) and Medical Management
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.
Full 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.
Eligibility Criteria
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
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There are 49 Locations for this study
Little Rock Arkansas, 72205, United States
Beverly Hills California, 90211, United States
Los Angeles California, 90033, United States
San Diego California, 92123, United States
Stanford California, 94305, United States
New Haven Connecticut, 06510, United States
Gainesville Florida, 35610, United States
Tampa Florida, 33606, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30342, United States
Chicago Illinois, 60637, United States
Oak Lawn Illinois, 60453, United States
Indianapolis Indiana, 46260, United States
Louisville Kentucky, 40202, United States
Detroit Michigan, 48202, United States
Ypsilanti Michigan, 48197, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55455, United States
Rochester Minnesota, 55905, United States
Kansas City Missouri, 64111, United States
Saint Louis Missouri, 63110, United States
Newark New Jersey, 07112, United States
Robbinsville New Jersey, 08691, United States
Albuquerque New Mexico, 87102, United States
Bronx New York, 10467, United States
New York New York, 10029, United States
New York New York, 10032, United States
Poughkeepsie New York, 12601, United States
Rochester New York, 14642, United States
Chapel Hill North Carolina, 27599, United States
Durham North Carolina, 27710, United States
Fargo North Dakota, 58122, United States
Cleveland Ohio, 44109, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43214, United States
Oklahoma City Oklahoma, 73112, United States
Tulsa Oklahoma, 74104, United States
Portland Oregon, 97239, United States
Abington Pennsylvania, 19001, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19104, United States
Dallas Texas, 75226, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84132, United States
Falls Church Virginia, 22042, United States
Falls Church Virginia, 22042, United States
Richmond Virginia, 23298, United States
Seattle Washington, 98195, United States
Milwaukee Wisconsin, 53233, United States
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