Table 2.

Inclusion and exclusion criteria: evaluated at consent (enrolment) and randomization

Inclusion criteria

Subject will receive the HM3 per standard of care in accordance with the approved indications for use in the country of implant. Subject will receive the HM3 as their first durable ventricular assist device. Subject must provide written informed consent prior to any clinical investigation‐related procedure. In patients of child‐bearing capability, not currently pregnant and on appropriate contraception.

Exclusion criteria

Post‐implant additional temporary or permanent MCS post‐implant (other than the HM3 LVAD). Post‐implant investigator mandated antiplatelet therapy for other conditions (including mandated presence or absence of antiplatelet agent). Patients who are nil per os post‐implant through day 7. Subjects with a known allergy to acetylsalicylic acid. Participation in any other clinical investigation(s) involving an MCS device, or interventional investigation(s) likely to confound study results or affect study outcome. 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.

HM3, HeartMate 3; LVAD, left ventricular assist device; MCS, mechanical circulatory support.