NCT06655376 Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients With Assist Device
| NCT ID | NCT06655376 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Columbia University |
| Condition | Bleeding |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2024-10-02 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 128 participants in total. It began in 2024-10-02 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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
Contact & Investigator
Nir Uriel, MD
PRINCIPAL INVESTIGATOR
Seymour, Paul, and Gloria Milstein Professor of Cardiology at Columbia University
Frequently Asked Questions
Who can join the NCT06655376 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bleeding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06655376 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06655376 currently recruiting?
Yes, NCT06655376 is actively recruiting participants. Contact the research team at nu2126@cumc.columbia.edu for enrollment information.
Where is the NCT06655376 trial being conducted?
This trial is being conducted at Chicago, United States, New York, United States, Houston, United States.
Who is sponsoring the NCT06655376 clinical trial?
NCT06655376 is sponsored by Columbia University. The principal investigator is Nir Uriel, MD at Seymour, Paul, and Gloria Milstein Professor of Cardiology at Columbia University. The trial plans to enroll 128 participants.