Columbia University
This study is being done to learn the safety and efficacy of a new anticoagulant therapy with apixaban as compared to warfarin to prevent thrombotic events while protecting from bleeding complications in patients with advanced heart failure who are chronically supported by a HeartMate 3 Left Ventricular Assist Device for 3 months.
Heart failure is a global epidemic, and Left Ventricular Assist Devices (LVADs) - particularly the HeartMate 3 (HM3) - are increasingly used due to their survival benefit over medical therapy. Despite advances, hemocompatibility-related adverse events (HRAEs) like thrombosis and bleeding remain significant causes of morbidity and mortality. Direct Oral Anticoagulants (DOACs) have shown superiority over warfarin in heart failure patients, with lower rates of embolic and intracranial bleeding. Reduced-dose DOACs also appear to reduce major bleeding without increasing thrombotic risk. However, d…
Inclusion Criteria: * Participants will have HeartMate3 LVAD implanted \> 3 months before enrollment * ≥ 18 years old * Treated with WARFARIN SODIUM * Participant must provide written informed consent prior to any clinical investigation related procedure * In female participants of childbearing capability, not currently pregnant and on appropriate contraception Exclusion Criteria: * Participation in any other clinical investigation(s) involving a Mechanical Circulatory Support (MCS) device, or interventional investigation(s) likely to confound study results or affect study outcome * Presenc…
Warfarin dose titrated for an International Normalized Ratio (INR) \>= 1.8
Apixaban 5 mg bid (twice a day)
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