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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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