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.

View Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

200

Study ID:

NCT01452802

Recruitment Status:

Completed

Sponsor:

Abbott Medical Devices

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There are 49 Locations for this study

See Locations Near You

Baptist Medical Center
Little Rock Arkansas, 72205, United States
Cedars Sinai Medical Center
Beverly Hills California, 90211, United States
Keck Medical Center of USC
Los Angeles California, 90033, United States
Sharp Memorial Hospital
San Diego California, 92123, United States
Stanford University
Stanford California, 94305, United States
Yale New Haven Hospital
New Haven Connecticut, 06510, United States
Shands Hospital at University of Florida
Gainesville Florida, 35610, United States
Tampa General Hospital
Tampa Florida, 33606, United States
Emory University Hospital
Atlanta Georgia, 30322, United States
St. Joseph's Hospital / Atlanta
Atlanta Georgia, 30342, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States
Advocate Christ Medical Center
Oak Lawn Illinois, 60453, United States
St. Vincent's Hospitals and Health Services
Indianapolis Indiana, 46260, United States
Jewish Hospital
Louisville Kentucky, 40202, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Michigan Heart
Ypsilanti Michigan, 48197, United States
Minneapolis Heart Institute Foundation
Minneapolis Minnesota, 55407, United States
University of Minnesota Medical Center
Minneapolis Minnesota, 55455, United States
Mayo Clinic Rochester
Rochester Minnesota, 55905, United States
St. Luke's Hospital of Kansas City
Kansas City Missouri, 64111, United States
Barnes Jewish Hospital
Saint Louis Missouri, 63110, United States
Newark Beth Israel Medical Center
Newark New Jersey, 07112, United States
Mercer Bucks Cardiology
Robbinsville New Jersey, 08691, United States
New Mexico Heart Institute
Albuquerque New Mexico, 87102, United States
Montefiore Medical Center
Bronx New York, 10467, United States
Mt. Sinai Medical Center
New York New York, 10029, United States
Columbia University Medical Center
New York New York, 10032, United States
Hudson Valley Heart Center
Poughkeepsie New York, 12601, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
University of North Carolina
Chapel Hill North Carolina, 27599, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Sanford Medical Center
Fargo North Dakota, 58122, United States
The Metro Health System
Cleveland Ohio, 44109, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Ohio State University Medical Center
Columbus Ohio, 43210, United States
Riverside Methodist Hospital
Columbus Ohio, 43214, United States
INTEGRIS Baptist Medical Center, Inc.
Oklahoma City Oklahoma, 73112, United States
St. John Medical Center
Tulsa Oklahoma, 74104, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Abington Memorial Hospital
Abington Pennsylvania, 19001, United States
Penn State Milton Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Baylor University Medical Center
Dallas Texas, 75226, United States
Memorial Hermann, TMC
Houston Texas, 77030, United States
Methodist Hospital
Houston Texas, 77030, United States
Texas Heart Institute
Houston Texas, 77030, United States
University of Utah Medical School
Salt Lake City Utah, 84132, United States
Inova Fairfax Hospital
Falls Church Virginia, 22042, United States
Virginia Heart
Falls Church Virginia, 22042, United States
Virginia Commonwealth University
Richmond Virginia, 23298, United States
University of Washington Medical Center
Seattle Washington, 98195, United States
St. Luke's Medical Center
Milwaukee Wisconsin, 53233, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

200

Study ID:

NCT01452802

Recruitment Status:

Completed

Sponsor:


Abbott Medical Devices

How clear is this clinincal trial information?

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