Actively Recruiting
Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients With Assist Device
Led by Columbia University · Updated on 2026-02-27
128
Participants Needed
3
Research Sites
130 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
W
Weill Medical College of Cornell University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 newer LVAD technology, the HeartMate 3 (Abbott, Chicago, IL), however, hemocompatibility related adverse events, including thrombosis and bleeding, are still a major cause of morbidity and mortality. The recent ARIES trial showed that in patients with advanced heart failure treated with a HeartMate3 LVAD, avoidance of aspirin as part of an antithrombotic regimen, which includes vitamin K antagonist (VKA), is not inferior to a regimen containing aspirin, does not increase thromboembolism risk, and is associated with a reduction in bleeding events. This clinical investigation is a prospective, randomized, controlled study of advanced heart failure patients supports with the HeartMate3 for more then 3 months with two different antithrombotic regimens: VKA with and without aspirin. The objective of this investigation is to study the safety and efficacy of an antithrombotic regimen without antiplatelet therapy.
CONDITIONS
Official Title
Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients With Assist Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has had a HeartMate 3 LVAD implanted for more than 3 months before enrollment
- Participant is 18 years old or older
- Currently treated with aspirin and vitamin K antagonist (VKA)
- Participant provides written informed consent before any study procedures
You will not qualify if you...
- Doctor requires antiplatelet therapy for other conditions, including mandated use or avoidance of antiplatelet agents
- Participation in other clinical studies involving mechanical circulatory support devices or interventions that may affect study results
- Presence of other medical, anatomical, social, or psychological conditions that could limit participation or affect study outcomes, as judged by the investigator
- Currently pregnant or using appropriate contraception
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
2
Columbia Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
3
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
N
Nir Uriel, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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