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



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:2/1/2019
Start Date:October 2011
End Date:June 2016

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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
We found this trial at
52
sites
1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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Dallas, TX
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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Falls Church, VA
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Gainesville, FL
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Rochester, NY
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Tampa, FL
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Albuquerque, New Mexico 87102
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Albuquerque, NM
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Atlanta, Georgia 30342
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta, GA
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Beverly Hills, California 90211
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Beverly Hills, CA
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Chapel Hill, NC
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Cleveland, Ohio 44109
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Falls Church, Virginia 22042
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Falls Church, VA
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Fargo, North Dakota 58122
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Fargo, ND
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Hershey, Pennsylvania 17033
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Houston, Texas 77225
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Houston, Texas 77030
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Houston, Texas 77030
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Indianapolis, Indiana 46260
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Kansas City, Missouri 64111
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Little Rock, Arkansas 72205
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Los Angeles, California 90033
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Louisville, Kentucky 40202
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Milwaukee, Wisconsin 53215
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Minneapolis, Minnesota 55407
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Minneapolis, Minnesota 55455
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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New York, New York 10029
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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4440 West 95th Street
Oak Lawn, Illinois 60453
708.684.8000
Advocate Christ Medical Center Advocate Health Care, named among the nation
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Oklahoma City, Oklahoma
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Poughkeepsie, New York 12601
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Robbinsville, New Jersey 08691
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Saint Louis, Missouri 63110
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Salt Lake City, Utah 84132
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7901 Frost Street
San Diego, California 92123
858-939-3400
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Tulsa, Oklahoma 74104
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Ypsilanti, Michigan 48197
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