Tests whether aspirin is needed with blood thinner for heart pump patients
Compares blood thinner treatment with and without aspirin in adults with a heart assist device.
Plain-language title generated from the registry record
Registry title: Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients With Assist Device
Key facts
- Where
- Chicago, Houston, and New York, United StatesSee the 3 sites
- Phase
- Phase 4
Where in United States
- University of ChicagoChicago, United StatesTaking people
- The University of Texas Health Science Center at HoustonHouston, United StatesTaking people
- Columbia Irving Medical CenterNew York, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Columbia University
- Trial code
- NCT06655376
- Record updated
- 27 February 2026
- Original description
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.Read full original descriptionShow less
Delayed ARIES: Aspirin and Hemocompatibility Events in Advanced Heart Failure Patients Chronically Supported With a Left Ventricular Assist Device
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.
Inclusion: 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: 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; 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.