RECRUITING

Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients with Assist Device

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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.

Official Title

Delayed ARIES: Aspirin and Hemocompatibility Events in Advanced Heart Failure Patients Chronically Supported with a Left Ventricular Assist Device

Quick Facts

Study Start:2024-10-02
Study Completion:2027-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06655376

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant will have HeartMate3 LVAD implanted \> 3 months before enrollment.
  2. * \>18 years old
  3. * Treated with aspirin and VKA
  4. * Participant must provide written informed consent prior to any clinical investigation-related procedure
  1. * Investigator-mandated antiplatelet therapy for other conditions (including mandated presence or absence of antiplatelet agent)
  2. * Participation in any other clinical investigation(s) involving an MCS device, or interventional investigation(s) likely to confound study results or affect study outcome
  3. * 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
  4. * Pregnant and on appropriate contraception

Contacts and Locations

Study Contact

Boaz Elad, MD
CONTACT
2123057600
be2335@cumc.columbia.edu

Principal Investigator

Nir Uriel, MD
PRINCIPAL_INVESTIGATOR
Seymour, Paul, and Gloria Milstein Professor of Cardiology at Columbia University

Study Locations (Sites)

Columbia Irving Medical Center
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Nir Uriel, MD, PRINCIPAL_INVESTIGATOR, Seymour, Paul, and Gloria Milstein Professor of Cardiology at Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-02
Study Completion Date2027-04-01

Study Record Updates

Study Start Date2024-10-02
Study Completion Date2027-04-01

Terms related to this study

Additional Relevant MeSH Terms

  • Bleeding
  • Clot Blood