Heart Failure Clinical Trial
The ARIES HeartMate 3 Pump IDE Study
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
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.
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.
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.
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There are 50 Locations for this study
Little Rock Arkansas, 72205, United States
La Jolla California, 92037, United States
Palo Alto California, 94304, United States
San Diego California, 92123, United States
San Francisco California, 94109, United States
Aurora Colorado, 80045, United States
Washington District of Columbia, 20010, United States
Miami Florida, 33136, United States
Orlando Florida, 32804, United States
Atlanta Georgia, 30309, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60637, United States
Oak Lawn Illinois, 60453, United States
Indianapolis Indiana, 46240, United States
Kansas City Kansas, 66160, United States
New Orleans Louisiana, 70121, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48202, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55455, United States
New York New York, 10029, United States
New York New York, 10032, United States
New York New York, 10467, United States
Rochester New York, 14642, United States
Chapel Hill North Carolina, 27599, United States
Charlotte North Carolina, 28203, United States
Durham North Carolina, 27710, United States
Cincinnati Ohio, 45219, United States
Cleveland Ohio, 44195, United States
Oklahoma City Oklahoma, 73112, United States
Portland Oregon, 97225, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15213, United States
Dallas Texas, 75246, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84132, United States
Milwaukee Wisconsin, 53215, United States
Darlinghurst New, 2010, Australia
Melbourne Victoria, 3004, Australia
Vienna , 1090, Austria
Edmonton , T6G 2, Canada
Prague Central Bohemia, 140 2, Czechia
Pessac , 33600, France
Toulouse , 31000, France
Milan , , Italy
Astana , 10000, Kazakhstan
Birmingham , B15 2, United Kingdom
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