Heart Failure Clinical Trial

The ARIES HeartMate 3 Pump IDE Study

Summary

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

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Full Description

This clinical investigation is a prospective, randomized, double-blinded, placebo-controlled study 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

Heart Failure

Estimated Enrollment:

628

Study ID:

NCT04069156

Recruitment Status:

Active, not recruiting

Sponsor:

Abbott Medical Devices

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There are 50 Locations for this study

See Locations Near You

Baptist Health Medical Center
Little Rock Arkansas, 72205, United States
University of California, San Diego
La Jolla California, 92037, United States
Stanford University Medical Center
Palo Alto California, 94304, United States
Sharp Memorial Hospital
San Diego California, 92123, United States
California Pacific Medical Center - Van Ness Campus
San Francisco California, 94109, United States
University of Colorado Hospital
Aurora Colorado, 80045, United States
Washington Hospital Center
Washington District of Columbia, 20010, United States
Miami Transplant Institute - Jackson Memorial
Miami Florida, 33136, United States
AdventHealth Orlando
Orlando Florida, 32804, United States
Piedmont Heart Institute
Atlanta Georgia, 30309, United States
Emory University Hospital
Atlanta Georgia, 30322, United States
University of Chicago
Chicago Illinois, 60637, United States
Advocate Christ Medical Center
Oak Lawn Illinois, 60453, United States
St. Vincent Hospital
Indianapolis Indiana, 46240, United States
Kansas University Medical Center
Kansas City Kansas, 66160, United States
Ochsner Medical Center
New Orleans Louisiana, 70121, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Brigham & Women's Hospital
Boston Massachusetts, 02115, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Minneapolis Heart Institute
Minneapolis Minnesota, 55407, United States
University of Minnesota Medical Center Fairview
Minneapolis Minnesota, 55455, United States
Mount Sinai Hospital
New York New York, 10029, United States
New York-Presbyterian/Columbia University Medical Center
New York New York, 10032, United States
Montefiore Medical Center - Moses Division
New York New York, 10467, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27599, United States
Carolinas Medical Center
Charlotte North Carolina, 28203, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
The Christ Hospital
Cincinnati Ohio, 45219, United States
The Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Integris Baptist Medical Center
Oklahoma City Oklahoma, 73112, United States
Providence Heart & Vascular Institute
Portland Oregon, 97225, United States
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States
Allegheny General Hospital - ASRI
Pittsburgh Pennsylvania, 15212, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15213, United States
Baylor University Hospital
Dallas Texas, 75246, United States
Memorial Hermann Hospital
Houston Texas, 77030, United States
University of Utah Hospital
Salt Lake City Utah, 84132, United States
Aurora Medical Group
Milwaukee Wisconsin, 53215, United States
St. Vincent's Hospital, Sydney
Darlinghurst New, 2010, Australia
The Alfred Hospital
Melbourne Victoria, 3004, Australia
AKH - Wien
Vienna , 1090, Austria
University of Alberta Hospital
Edmonton , T6G 2, Canada
IKEM Prague
Prague Central Bohemia, 140 2, Czechia
Hopital Haut Leveque
Pessac , 33600, France
CHU Rangueil Toulouse
Toulouse , 31000, France
Ospedale San Raffaele
Milan , , Italy
National Research Center for Cardiac Surgery
Astana , 10000, Kazakhstan
Queen Elizabeth Hospital
Birmingham , B15 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

628

Study ID:

NCT04069156

Recruitment Status:

Active, not recruiting

Sponsor:


Abbott Medical Devices

How clear is this clinincal trial information?

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