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

Completed

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT01452802

Run by

Abbott Medical Devices

People needed

200

Starts

2011-10-01

Expected to finish

2016-06-01

Last updated by the study team

2022-06-24

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• Baptist Medical Center — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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