The ARIES HeartMate 3 Pump IDE Study

Completed · Not applicable · Has a placebo group

Conditions studied: Heart Failure

In brief

Prospective, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo

Key facts

Study ID

NCT04069156

Run by

Abbott Medical Devices

People needed

628

Starts

2020-07-14

Expected to finish

2023-08-10

Last updated by the study team

2025-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject will receive the HeartMate 3 per standard of care (SOC) in accordance with the approved indications for use in the country of implant.
• Subject will receive the HeartMate 3 as their first durable VAD.
• Subject must provide written informed consent prior to any clinical investigation related procedure.
• In female patients of child bearing capability, subject will not be currently pregnant or breastfeeding and on appropriate contraception.

You may not qualify if…

• Post-implant additional temporary or permanent mechanical circulatory support (MCS).
• Investigator mandated antiplatelet therapy for other conditions (including mandated presence or absence of antiplatelet agent).
• Patients who are nil per os (NPO) post-implant through day 7.
• Subjects with a known allergy to acetylsalicylic acid (aspirin).
• 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.

Where it is running

• University of California, San Diego — La Jolla, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• California Pacific Medical Center - Van Ness Campus — San Francisco, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Miami Transplant Institute - Jackson Memorial — Miami, Florida, United States
• AdventHealth Orlando — Orlando, Florida, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• St. Vincent Hospital — Indianapolis, Indiana, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Minneapolis Heart Institute — Minneapolis, Minnesota, United States
• University of Minnesota Medical Center Fairview — Minneapolis, Minnesota, United States
• Mount Sinai Hospital — New York, New York, United States
• New York-Presbyterian/Columbia University Medical Center — New York, New York, United States
• Montefiore Medical Center - Moses Division — New York, New York, United States
• Baptist Health Medical Center — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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