Actively Recruiting
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
3
Research Sites
N/A
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 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 year
Participants are randomized to receive either Warfarin alone or Warfarin together with Aspirin as part of their antithrombotic regimen while chronically supported with the HeartMate 3 LVAD.
Regular visits to adjust medication and monitor safety and efficacy
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here