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

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.

Eligibility Criteria

Inclusion Criteria

- Subject is receiving the HM II per standard of care (SOC) in accordance with the FDA
approved indications for use

- Subject is ≥ 60 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).

Exclusion Criteria

- Existence of ongoing mechanical circulatory support (MCS) other than intra-aortic
balloon pump

- 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

- Subjects in whom heart transplantation is expected in ≤ 6 months

- Subjects with a known ASA allergy

Principal Investigator

Travis Abicht, M.D.

Study Contact

Carrie Vooght, cvooght@sjm.com, 781-852-8354

Estimated Completion Date

Thursday, October 1, 2020

ClinicalTrials.gov #