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

NCT01452802 | Completed

• 1 other identifier: TC07272011
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 52

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.

Conditions

Heart Failure

Keywords

HeartMate II; heart-assist device; medical management; optimal medical management; Heart Failure NYHA Class IIIB/IV; Thoratec Corporation

Outcome Measures

Primary Outcomes (1)

• Composite of survival with improvement in Six Minute Hallway Walk Test distance from baseline of ≥ 75m.

  12 months

Secondary Outcomes (9)

• Risk stratified subgroup analysis of the primary endpoint and temporal analysis of primary endpoint.

  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

• Actuarial survival and survival free of stroke: a) intent-to-treat; and b) as treated.

  24 months

• Survival in LVAD group free of pump replacement.

  24 months

• Quality of Life using the EQ-5D-5L Health Utility Index.

  Baseline and 6, 12, 18 and 24 months

Study Arms (2)

HM II (HeartMate II LVAD)

Subjects who elect to, and receive HM II LVAD therapy at baseline

Device: HM II (HeartMate II LVAD)

OMM (Optimal Medical Management)

Subjects who elect to remain on optimal medical management

Drug: OMM (Optimal Medical Management)

Interventions

HM II (HeartMate II LVAD) DEVICE

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.

Also known as: Left Ventricular Assist Device

HM II (HeartMate II LVAD)

OMM (Optimal Medical Management) DRUG

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.

Also known as: Medical Management

OMM (Optimal Medical Management)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HM II implanting centers and community/referral heart failure clinics

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead
• Thoratec Corporation: collaborator

Study Sites (52)

Baptist Medical Center

Little Rock, Arkansas, 72205, United States

Location

Cedars Sinai Medical Center

Beverly Hills, California, 90211, United States

Location

Keck Medical Center of USC

Los Angeles, California, 90033, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Shands Hospital at University of Florida

Gainesville, Florida, 35610, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

St. Joseph's Hospital / Atlanta

Atlanta, Georgia, 30342, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

St. Vincent's Hospitals and Health Services

Indianapolis, Indiana, 46260, United States

Location

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Michigan Heart

Ypsilanti, Michigan, 48197, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

St. Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Mercer Bucks Cardiology

Robbinsville, New Jersey, 08691, United States

Location

New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States

Location

Mt. Sinai Medical Center

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Hudson Valley Heart Center

Poughkeepsie, New York, 12601, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Sanford Medical Center

Fargo, North Dakota, 58122, United States

Location

The Metro Health System

Cleveland, Ohio, 44109, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

INTEGRIS Baptist Medical Center, Inc.

Oklahoma City, Oklahoma, 73112, United States

Location

St. John Medical Center

Tulsa, Oklahoma, 74104, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Penn State Milton Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Baylor University Medical Center

Dallas, Texas, 75226, United States

Location

Memorial Hermann, TMC

Houston, Texas, 77030, United States

Location

Methodist Hospital

Houston, Texas, 77030, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

University of Utah Medical School

Salt Lake City, Utah, 84132, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Virginia Heart

Falls Church, Virginia, 22042, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

St. Luke's Medical Center

Milwaukee, Wisconsin, 53233, United States

Location

Related Publications (4)

• 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.

  PMID: 28611126 DERIVED

• 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.

  PMID: 28465311 DERIVED

• 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.

  PMID: 28396040 DERIVED

• 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.

  PMID: 26483097 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Practice Management, Medical

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• David Farrar, PhD

  Abbott Medical Devices

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2011
• First Posted: October 17, 2011
• Study Start: October 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

US (52)