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

This is a post-market clinical study of HM II patient management practices to be conducted in
the United States.

Subjects will be randomized in a 1:1 fashion to the following research drug groups:

1. Treatment Arm: Warfarin (INR target: 2.0-2.5, median: 2.25) + Placebo (1 pill/day)

2. Control Arm: Warfarin (INR target: 2.0-2.5, median: 2.25) + ASA Therapy (81mg/day)

The study will investigate if subjects in the Treatment Arm experience a reduced incidence of
non-surgical bleeding, without an increased risk of TE events.

Inclusion Criteria

- 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).

Exclusion Criteria

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