Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy

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 Destination Therapy in end-stage heart failure patients who do not qualify for cardiac transplantation. The Destination Therapy indication for use was approved by FDA on January 20, 2010 (ref. PMA P060040/S005).

Key facts

Study ID

NCT00121485

Run by

Abbott Medical Devices

People needed

200

Starts

2005-02-01

Expected to finish

2012-01-01

Last updated by the study team

2022-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The following are general criteria; more specific conditions are included in the study protocol:
• Subjects with advanced heart failure symptoms (NYHA Class IIIB or IV) who are:
• On optimal medical management and are failing to respond; or
• In Class III or Class IV heart failure and dependent on IABP and/or inotropes; or
• Treated with ACE inhibitors or beta-blockers and found to be intolerant.
• Ineligible for cardiac transplant
• VO2max <=14 ml/kg/min
• LVEF <=25%

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
• University of Colorado Hospital — Denver, Colorado, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Shands Hospital @ University of Florida — Gainesville, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• Methodist Hospital — Indianapolis, Indiana, United States
• Jewish Hospital — Louisville, Kentucky, United States
• University of Maryland School of Medicine — Baltimore, Maryland, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Tufts / New England Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham & Women's 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
• Mayo Clinic — Rochester, Minnesota, United States
• Barnes-Jewish Hospital/Washington University — St Louis, Missouri, United States
• Bryan LGH Heart Institute — Lincoln, Nebraska, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• New York Columbia Presbyterian Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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