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

• Status: Completed
• Trial end date: 2019-07-18
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott Medical Devices; St. Jude Medical
• Treatments: Aspirin; Warfarin

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 ≥ 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 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