HVP_SJM CIP-10134 PREVENT II
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.
Key Inclusion Criteria:
1. Subject is receiving the HM II per standard of care (SOC) in accordance with the FDA approved indications for use
2. Subject is ≥ 60 years of age
3. Subject is receiving the HM II as their first LVAD
4. Subject or legally authorized representative (LAR) has signed an informed consent form (ICF).
See clinicaltrials.gov for full details.
Heart and Vascular,
Jacob Abraham MD
- Providence St. Vincent Medical Center