Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
Prospective, randomized, double-blinded, placebo-controlled clinical investigation of
advanced heart failure patients treated with the HM3 with two different antithrombotic
regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo
Phase
N/A
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
Inclusion Criteria:
1. Subject will receive the HeartMate 3 per standard of care (SOC) in accordance with the
approved indications for use in the country of implant.
2. Subject will receive the HeartMate 3 as their first durable VAD.
3. Subject must provide written informed consent prior to any clinical investigation
related procedure.
4. In female patients of child bearing capability, subject will not be currently pregnant
or breastfeeding and on appropriate contraception.
Exclusion Criteria:
1. Post-implant additional temporary or permanent mechanical circulatory support (MCS).
2. Investigator mandated antiplatelet therapy for other conditions (including mandated
presence or absence of antiplatelet agent).
3. Patients who are nil per os (NPO) post-implant through day 7.
4. Subjects with a known allergy to acetylsalicylic acid (aspirin).
5. Participation in any other clinical investigation(s) involving an MCS device, or
interventional investigation(s) likely to confound study results or affect study
outcome.
6. Presence of other anatomic or comorbid conditions, or other medical, social, or
psychological conditions that, in the investigator's opinion, could limit the
subject's ability to participate in the clinical investigation or to comply with
follow-up requirements, or impact the scientific soundness of the clinical
investigation results.