Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy

Completed · Phase 4

Conditions studied: Heart Failure

In brief

This study is a prospective, multi-center, randomized, double-blind placebo-controlled study of subjects receiving the HM II LVAD as per the current FDA approved indications for use.

Key facts

Study ID

NCT02836652

Run by

Abbott Medical Devices

People needed

72

Starts

2016-11-01

Expected to finish

2019-07-18

Last updated by the study team

2022-06-27

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is receiving the HM II per standard of care (SOC) in accordance with the FDA approved indications for use
• Subject is ≥ 50 years of age
• Subject is receiving the HM II as their first LVAD
• Subject or legally authorized representative (LAR) has signed an informed consent form (ICF).

You may not qualify if…

• Existence of ongoing mechanical circulatory support (MCS) other than intra-aortic balloon pump or Impella® devices
• Participation in any other clinical investigation(s) involving an MCS device, or an investigation(s) that is likely to confound study results or affect study outcome
• Antiplatelet therapy is mandated for other conditions, in particular: a) recent coronary artery stenting (≤ 6 months), b) carotid artery disease, and c) other conditions where the investigator is not comfortable leaving subjects off-ASA or starting ASA post LVAD implantation. In situations where the investigator is uncertain, the Steering Committee can provide recommendation to the investigator as needed.
• Subjects in whom heart transplantation is expected in ≤ 6 months
• Subjects with a known ASA allergy

Where it is running

• University of Alabama Hospital at Birmingham (UAB) — Birmingham, Alabama, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• University of California at San Francisco — San Francisco, California, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Shands at the University of Florida — Gainesville, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• St. Vincent Hospital — Indianapolis, Indiana, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• University of Minnesota Medical Center Fairview — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• New York Presbyterian Hospital/Columbia University — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Westchester Medical Center — Valhalla, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Christ Hospital — Cincinnati, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Integris Baptist Medical Center — Oklahoma City, Oklahoma, United States
• Providence St. Vincent — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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