Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation

Completed · Not applicable

Conditions studied: Heart Failure, Congestive, Ventricular Dysfunction, Cardiomyopathies

In brief

The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as a bridge to cardiac transplantation in end-stage heart failure patients who are listed for cardiac transplant but are at imminent risk of dying. The HeartMate II LVAS was approved by the US FDA on April 21, 2008, as a bridge to cardiac transplantation (reference PMA P060040). It was approved for commercial distribution in Canada on May 20, 2009 (reference Medical Device Licence #79765). Patients enrolled into the clinical trial will continue to be followed until all have reached a clinical outcome.

Key facts

Study ID

NCT00121472

Run by

Abbott Medical Devices

People needed

194

Starts

2005-03-01

Expected to finish

2010-05-01

Last updated by the study team

2022-06-27

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The following are general criteria; more specific conditions are included in the study protocol:
• Listed for cardiac transplantation
• NYHA Class IV heart failure symptoms
• On inotropic support, if tolerated
• Despite medical therapy, the patient must meet hemodynamic criteria for cardiogenic shock

You may not qualify if…

• The following are general criteria; more specific conditions are included in the study protocol:
• Evidence of, or risk factors for end-organ dysfunction that would make LVAS implantation futile
• Existence of factors that would adversely affect patient survival or function of the LVAS.
• Intolerance to anticoagulant or antiplatelet therapies.
• Existence of any ongoing mechanical circulatory support other than intra-aortic balloon counterpulsation.
• Participation in any other clinical investigation that is likely to confound study results or affect study outcome.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Mayo Clinic Hospital — Phoenix, Arizona, United States
• Sharp Memorial Hospital — San Diego, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Shands Hospital @ University of Florida — Gainesville, Florida, United States
• Methodist Hospital — Indianapolis, Indiana, United States
• Jewish Hospital — Louisville, Kentucky, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Barnes-Jewish Hospital/Washington University — St Louis, Missouri, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• New York Columbia Presbyterian Medical Center — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• INTEGRIS Baptist Medical Center — Oklahoma City, Oklahoma, United States
• Hospital of University of PA — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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