Principal Investigator: Craig Selzman
Keywords: LVAD , Aspirin , Heart Failure , Anticoagulation , MCS , Left ventricular assist device , HeartMate 3 Department: Cardiothoracic Division
IRB Number: 00130350 Co Investigator: Stavros Drakos
Specialty: Cardiology, Transplant Surgery, Cardiothoracic Surgery, Cardiothoracic Surgery
Sub Specialties: Heart Failure, Heart Failure, Heart Transplant
Recruitment Status: Not yet recruiting

Contact Information

Ashley Elmer
ashley.elmer@hsc.utah.edu
801-585-6775

Brief Summary

Clinical Investigation Objective

To study the safety and efficacy of an anti-platelet-free antithrombotic regimen in patients with advanced heart failure treated with the HeartMate 3 (HM3) LVAS.

Hypothesis

Withdrawal of antiplatelet therapy from the antithrombotic regimen of HM3 pump patients will not adversely affect safety or efficacy of the HM3 and may reduce non-surgical bleeding.

Inclusion Criteria

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 patients of child bearing capability, subject will not be currently pregnant or breastfeeding and on appropriate contraception.

Exclusion Criteria

Exclusion Criteria

  1. Post-implant additional temporary or permanent mechanical circulatory support (MCS).
  2. Post-implant 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.