Status:

RECRUITING

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

Lead Sponsor:

Columbia University

Collaborating Sponsors:

Weill Medical College of Cornell University

The University of Texas Health Science Center, Houston

Conditions:

Bleeding

Clot Blood

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

Heart failure is a world epidemic. LVADs are increasingly used as they have demonstrated improved survival rates compared to optimal medical management. Improving outcomes have been seen with the newe...

Detailed Description

Objective: To study the safety and efficacy of an anti-platelet-free antithrombotic regimen in patients with advanced heart failure who are chronically supported with the HeartMate 3 LVAD. Hypothesis...

Eligibility Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Key Trial Info

Start Date :

October 2 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2027

Estimated Enrollment :

128 Patients enrolled

Trial Details

Trial ID

NCT06655376

Start Date

October 2 2024

End Date

April 1 2027

Last Update

February 27 2026

Active Locations (3)

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Page 1 of 1 (3 locations)

1

University of Chicago

Chicago, Illinois, United States, 60637

2

Columbia Irving Medical Center

New York, New York, United States, 10032

3

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

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