Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device (LVAD) and Medical Management
NCT ID: NCT01452802
Last Updated: 2022-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2011-10-31
2016-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HM II (HeartMate II LVAD)
Subjects who elect to, and receive HM II LVAD therapy at baseline
HM II (HeartMate II LVAD)
The HM II pump contains a single moving component, the rotor. The pump is implanted just below the left hemidiaphragm with the inflow attached to the apex of the left ventricle and the outflow graft anastomosed to the ascending aorta. Blood is pumped continuously throughout the cardiac cycle from the left ventricle to the aorta.
OMM (Optimal Medical Management)
Subjects who elect to remain on optimal medical management
OMM (Optimal Medical Management)
Optimal medical management per established heart failure guidelines for this subject population including ACE inhibitors, beta blockers and aldosterone antagonists 45 out of the last 60 days or an inability to tolerate neurohormonal antagonists.
Interventions
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HM II (HeartMate II LVAD)
The HM II pump contains a single moving component, the rotor. The pump is implanted just below the left hemidiaphragm with the inflow attached to the apex of the left ventricle and the outflow graft anastomosed to the ascending aorta. Blood is pumped continuously throughout the cardiac cycle from the left ventricle to the aorta.
OMM (Optimal Medical Management)
Optimal medical management per established heart failure guidelines for this subject population including ACE inhibitors, beta blockers and aldosterone antagonists 45 out of the last 60 days or an inability to tolerate neurohormonal antagonists.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Thoratec Corporation
INDUSTRY
Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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David Farrar, PhD
Role: STUDY_DIRECTOR
Abbott Medical Devices
Locations
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Baptist Medical Center
Little Rock, Arkansas, United States
Cedars Sinai Medical Center
Beverly Hills, California, United States
Keck Medical Center of USC
Los Angeles, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Stanford University
Stanford, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Shands Hospital at University of Florida
Gainesville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
St. Joseph's Hospital / Atlanta
Atlanta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
St. Vincent's Hospitals and Health Services
Indianapolis, Indiana, United States
Jewish Hospital
Louisville, Kentucky, United States
Henry Ford Hospital
Detroit, Michigan, United States
Michigan Heart
Ypsilanti, Michigan, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Mercer Bucks Cardiology
Robbinsville, New Jersey, United States
New Mexico Heart Institute
Albuquerque, New Mexico, United States
Mt. Sinai Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Hudson Valley Heart Center
Poughkeepsie, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Sanford Medical Center
Fargo, North Dakota, United States
The Metro Health System
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
INTEGRIS Baptist Medical Center, Inc.
Oklahoma City, Oklahoma, United States
St. John Medical Center
Tulsa, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Penn State Milton Hershey Medical Center
Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Baylor University Medical Center
Dallas, Texas, United States
Memorial Hermann, TMC
Houston, Texas, United States
Methodist Hospital
Houston, Texas, United States
Texas Heart Institute
Houston, Texas, United States
University of Utah Medical School
Salt Lake City, Utah, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Virginia Heart
Falls Church, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Countries
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References
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Stehlik J, Estep JD, Selzman CH, Rogers JG, Spertus JA, Shah KB, Chuang J, Farrar DJ, Starling RC; ROADMAP Study Investigators. Patient-Reported Health-Related Quality of Life Is a Predictor of Outcomes in Ambulatory Heart Failure Patients Treated With Left Ventricular Assist Device Compared With Medical Management: Results From the ROADMAP Study (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management). Circ Heart Fail. 2017 Jun;10(6):e003910. doi: 10.1161/CIRCHEARTFAILURE.116.003910.
Lanfear DE, Levy WC, Stehlik J, Estep JD, Rogers JG, Shah KB, Boyle AJ, Chuang J, Farrar DJ, Starling RC. Accuracy of Seattle Heart Failure Model and HeartMate II Risk Score in Non-Inotrope-Dependent Advanced Heart Failure Patients: Insights From the ROADMAP Study (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients). Circ Heart Fail. 2017 May;10(5):e003745. doi: 10.1161/CIRCHEARTFAILURE.116.003745.
Starling RC, Estep JD, Horstmanshof DA, Milano CA, Stehlik J, Shah KB, Bruckner BA, Lee S, Long JW, Selzman CH, Kasirajan V, Haas DC, Boyle AJ, Chuang J, Farrar DJ, Rogers JG; ROADMAP Study Investigators. Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients: The ROADMAP Study 2-Year Results. JACC Heart Fail. 2017 Jul;5(7):518-527. doi: 10.1016/j.jchf.2017.02.016. Epub 2017 Apr 5.
Estep JD, Starling RC, Horstmanshof DA, Milano CA, Selzman CH, Shah KB, Loebe M, Moazami N, Long JW, Stehlik J, Kasirajan V, Haas DC, O'Connell JB, Boyle AJ, Farrar DJ, Rogers JG; ROADMAP Study Investigators. Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients: Results From the ROADMAP Study. J Am Coll Cardiol. 2015 Oct 20;66(16):1747-1761. doi: 10.1016/j.jacc.2015.07.075.
Other Identifiers
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TC07272011
Identifier Type: -
Identifier Source: org_study_id
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