Study of Aspirin-Free Antithrombotic Treatment Versus Aspirin with Warfarin in Adults with HeartMate 3 LVAD for Advanced Heart Failure

What this Trial Is About

Heart failure is a global health issue, and left ventricular assist devices LVADs like the HeartMate 3 are increasingly used to improve survival for patients with advanced heart failure. Despite advances, complications related to blood compatibility, such as clotting and bleeding, remain serious concerns. This trial investigates the safety and effectiveness of using an antithrombotic regimen without aspirin in patients supported by the HeartMate 3 LVAD, building on previous findings that avoiding aspirin may reduce bleeding without increasing clotting risks. The study is a prospective, randomized, controlled trial comparing two treatment groups of advanced heart failure patients who have been supported by the HeartMate 3 LVAD for more than three months. One group will receive warfarin alone, with doses adjusted to maintain a specific blood clotting goal, while the other group will receive warfarin combined with aspirin, which is the current standard of care. Participants will be randomly assigned to one of these two antithrombotic regimens and followed over time to assess outcomes. Participants will be monitored for one year after randomization, with researchers tracking survival free from major hemocompatibility-related events like stroke, pump thrombosis, and significant bleeding. Secondary outcomes such as rates of bleeding, clotting, stroke, rehospitalization, and economic impact will also be evaluated. The study aims to enroll up to 128 patients to ensure sufficient power and includes regular follow-ups to assess safety, treatment adherence, and clinical events.

Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients With Assist Device