NCT06655376RecruitingPhase 4
Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients With Assist Device
Delayed ARIES: Aspirin and Hemocompatibility Events in Advanced Heart Failure Patients Chronically Supported With a Left Ventricular Assist Device
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 128 (estimated)
- First submitted
- 22 Oct 2024
- Start date
- 2 Oct 2024
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Columbia University
- Diseases
- Heart failure
- NCT number
- NCT06655376
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 128
- From 2 Oct 2024 to the primary completion date, 1 Apr 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Investigator-mandated antiplatelet therapy for other conditions (including mandated presence or absence of antiplatelet agent)
- 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
Other
- Participation in any other clinical investigation(s) involving an MCS device, or interventional investigation(s) likely to confound study results or affect study outcome
- Pregnant and on appropriate contraception
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| The University of Texas Health Science Center at Houston Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Columbia Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.