What is aspirin studying for patients with advanced heart failure using the HeartMate 3 device?

This trial is studying the safety and effects of stopping aspirin in patients with advanced heart failure supported by the HeartMate 3 device. Researchers want to see if avoiding aspirin while using warfarin affects the risk of serious blood-related problems like clotting and bleeding. The study is led by Columbia University and aims to improve treatment strategies for these patients.

Who may be eligible for this advanced heart failure clinical trial?

Adults aged 18 or older who have had a HeartMate 3 LVAD implanted for more than three months and are currently treated with both aspirin and a vitamin K antagonist like warfarin may be eligible. The trial accepts all genders. Participants should not be pregnant or required to take antiplatelet therapy for other conditions. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced heart failure clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses to attend visits may vary and are usually not covered. Participants can expect support for their treatment and monitoring without fees related to the trial procedures.

Actively Recruiting

Phase 4

Age: 18Years +

All Genders

ID06655376

Delayed ARIES Aspirin and Hemocompatibility Events in Advanced Heart Failure Patients Chronically Supported With a Left Ventricular Assist Device

Led by Columbia University · Updated on 2026-02-27

128

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

HeartMate3 LVAD implanted more than 3 months before enrollment
Age 18 years or older
Currently treated with aspirin and a vitamin K antagonist (VKA)
Able and willing to provide written informed consent before any study procedures

You will not qualify if you...

Required antiplatelet therapy for other medical conditions as determined by the investigator
Participation in other clinical investigations involving mechanical circulatory support devices or interventions that may affect study results
Presence of medical, social, or psychological conditions that could limit participation or compliance with follow-up
Pregnant or not using appropriate contraception

Research Team

Nir Uriel, MD

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