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Aspirin and Bleeding/Clotting Events in HeartMate3 LVAD Patients

This study is looking at whether patients with advanced heart failure who have a HeartMate3 LVAD (a mechanical heart pump) can safely stop taking aspirin. Currently, these patients take both aspirin and warfarin (a blood thinner) to prevent clots. The study wants to see if removing aspirin from this treatment plan will reduce bleeding without increasing the risk of clots. You could be eligible if you are over 18, have had a HeartMate3 LVAD for more than 3 months, and are currently taking both aspirin and warfarin. The main goal is to see how many patients are free from major bleeding or clotting events one year after joining the study. This study plans to enroll 128 participants.

Study design
This is a randomized, controlled study, meaning participants will be randomly assigned to one of two treatment groups. It will compare taking warfarin with aspirin versus taking warfarin without aspirin.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one year after they are randomly assigned to a treatment group to track major bleeding or clotting events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06655376

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

Recruiting
PHASE4Ages 18+InterventionalTreatment
Columbia University
~128 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:AspirinWarfarin

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of survival free patients of any major hemocompatibility related adverse events.
Measured over 1 year post implant

Conditions

Bleeding
Clot Blood

Explore related trials

Heart Failure

NCT06655376

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Columbia Irving Medical Center

    New York, New Yorkstudy coordinator listed

    Recruiting

  • The University of Texas Health Science Center at Houston

    Houston, Texasno site contact published

    Recruiting

  • University of Chicago

    Chicago, Illinoisno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Nir Uriel, MD · PRINCIPAL_INVESTIGATOR · Seymour, Paul, and Gloria Milstein Professor of Cardiology at Columbia University

Who to contact

Nir Uriel, MD
[email protected]
2123057600
Email the study team

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Eligibility criteria

Inclusion

Participant will have HeartMate3 LVAD implanted \> 3 months before enrollment.
\>18 years old
Treated with aspirin and VKA
Participant must provide written informed consent prior to any clinical investigation-related procedure

Exclusion

Investigator-mandated antiplatelet therapy for other conditions (including mandated presence or absence of antiplatelet agent)
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
Pregnant and on appropriate contraception

What this trial measures

  • Number of survival free patients of any major hemocompatibility related adverse events.1 year post implant

    A Major Hemocompatibility Related Adverse Event is defined as: Stroke, Pump Thrombosis (suspected or confirmed), major non-surgical Bleeding (moderate or severe) (including intracranial bleeds that do not meet the stroke definition), Arterial Peripheral Thromboembolism. The events will be recorded and tallied per patient.