PREVENtion of HeartMate II Pump Thrombosis

Completed · Not applicable

Conditions studied: HeartMate II Pump Thrombosis

In brief

The purpose of this study is to assess how often blood clots form in the FDA-approved HeartMate® II (HM II) Left Ventricular Assist Device (LVAD) and to identify risks related to clotting within the pump.

Key facts

Study ID

NCT02158403

Run by

Abbott Medical Devices

People needed

300

Starts

2014-09-01

Expected to finish

2016-06-01

Last updated by the study team

2022-03-25

Who can join

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

You may qualify if…

• Subject or legally authorized representative has signed an informed consent form
• Subject is receiving the HeartMate II as their first Left Ventricular Assist Device (LVAD)

You may not qualify if…

• Prior mechanical circulatory support (MCS) (except for intra-aortic balloon pump)
• Participation in any other clinical investigation(s) involving a MCS device, or an investigation(s) that is likely to confound study results or affect study outcome

Where it is running

• Baptist Medical Center — Little Rock, Arkansas, United States
• University of California, San Diego — La Jolla, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Sutter Memorial — Sacramento, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• University of Colorado — Aurora, Colorado, United States
• Shands Hospital at University of Florida — Gainesville, Florida, United States
• Northwestern Memorial — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Jewish Hospital — Louisville, Kentucky, United States
• Abbott Northwestern — Minneapolis, Minnesota, United States
• University of Minnesota Medical Center — Minneapolis, Minnesota, United States
• Mayo Clinic, St. Mary's — Rochester, Minnesota, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Abington Memorial Hospital — Abington, Pennsylvania, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Memorial Hermann/UT Texas — Houston, Texas, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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