Clinical trial NCT04069156: The ARIES HeartMate 3 Pump IDE Study
Official title: Antiplatelet Removal and HemocompatIbility EventS With the HeartMate 3 Pump IDE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
ventricular assist device
LVAD
aspirin
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 628
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded, randomized 1:1, active arm versus placebo arm
Primary purpose: SUPPORTIVE_CARE

Brief 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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Post-implant additional temporary or permanent mechanical circulatory support (MCS).
2. Investigator mandated antiplatelet therapy for other conditions (including mandated presence or absence of antiplatelet agent).
3. Patients who are nil per os (NPO) post-implant through day 7.
4. Subjects with a known allergy to acetylsalicylic acid (aspirin).
5. Participation in any other clinical investigation(s) involving an MCS device, or interventional investigation(s) likely to confound study results or affect study outcome.
6. 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.

Primary outcomes:
measure: Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events
timeFrame: 12 Months
Secondary outcomes:
measure: Rates of Non-surgical Major Hemorrhagic Events
timeFrame: Through Study Completion with a Median Follow up of 14 Months
measure: Rates of Bleeding Events
timeFrame: Through Study Completion with a Median Follow up of 14 Months
measure: Rates of Non-surgical Major Thrombotic Events
timeFrame: Through Study Completion with a Median Follow up of 14 Months
measure: Rates of Stroke
timeFrame: Through Study Completion with a Median Follow up of 14 Months
measure: Survival Rates
timeFrame: 24 Months
measure: Risk of Non-Surgical Bleeding Events
timeFrame: 24 Months
Other outcomes:
measure: Rate of Rehospitalization
timeFrame: Through Study Completion with a Median Follow up of 14 Months
measure: Economic Cost Implications - Total Estimated Cost for Bleeding Events (CMS Cost Basis)
timeFrame: 12 Months
measure: Economic Cost Implications - Average Cost Per Bleeding Event
timeFrame: 12 Months
measure: Economic Cost Implications - Average Cost Per Study Patient Over the First-year Post-implant
timeFrame: 12 Months
measure: Economic Cost Implications - Cost of Bleeding Hospitalization for 1000 LVAD Implants Over the First-year Post-implant
timeFrame: 12 Months
Locations:
city: Little Rock
country: United States
facility: Baptist Health Medical Center
state: Arkansas
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center - Van Ness Campus
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Miami
country: United States
facility: Miami Transplant Institute - Jackson Memorial
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Hospital
state: Indiana
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center Fairview
state: Minnesota
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: New York-Presbyterian/Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Montefiore Medical Center - Moses Division
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center
state: Oklahoma
city: Portland
country: United States
facility: Providence Heart & Vascular Institute
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital - ASRI
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor University Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Milwaukee
country: United States
facility: Aurora Medical Group
state: Wisconsin
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital, Sydney
state: New
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Vienna
country: Austria
facility: AKH - Wien
city: Edmonton
country: Canada
facility: University of Alberta Hospital
city: Prague
country: Czechia
facility: IKEM Prague
state: Central Bohemia
city: Pessac
country: France
facility: Hopital Haut Leveque
city: Toulouse
country: France
facility: CHU Rangueil Toulouse
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: Astana
country: Kazakhstan
facility: National Research Center for Cardiac Surgery
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
Study officials:
References:
citation: Mehra MR, Netuka I, Uriel N, Katz JN, Pagani FD, Jorde UP, Gustafsson F, Connors JM, Ivak P, Cowger J, Ransom J, Bansal A, Takeda K, Agarwal R, Byku M, Givertz MM, Bitar A, Hall S, Zimpfer D, Vega JD, Kanwar MK, Saeed O, Goldstein DJ, Cogswell R, Sheikh FH, Danter M, Pya Y, Phancao A, Henderson J, Crandall DL, Sundareswaran K, Soltesz E, Estep JD; ARIES-HM3 Investigators. Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure: The ARIES-HM3 Randomized Clinical Trial. JAMA. 2023 Dec 12;330(22):2171-2181. doi: 10.1001/jama.2023.23204.
citation: Gustafsson F, Uriel N, Netuka I, Katz JN, Pagani FD, Connors JM, Jorde UP, Zimpfer D, Pya Y, Conway J, Anyanwu A, Scandroglio AM, Sulemanjee N, Atluri P, Keebler M, Selzman CH, Alexis JD, Hayward C, Henderson J, Dirckx N, Gazzola C, Mehra MR; ARIES Investigators. Aspirin and Hemocompatibility After LVAD Implantation in Patients With Atherosclerotic Vascular Disease: A Secondary Analysis From the ARIES-HM3 Randomized Clinical Trial. JAMA Cardiol. 2025 Mar 1;10(3):235-242. doi: 10.1001/jamacardio.2024.4849.
citation: Mehra MR, Crandall DL, Gustafsson F, Jorde UP, Katz JN, Netuka I, Uriel N, Connors JM, Sood P, Heatley G, Pagani FD. Aspirin and left ventricular assist devices: rationale and design for the international randomized, placebo-controlled, non-inferiority ARIES HM3 trial. Eur J Heart Fail. 2021 Jul;23(7):1226-1237. doi: 10.1002/ejhf.2275. Epub 2021 Jul 1.