The ARIES HeartMate 3 Pump IDE Study

NCT04069156 | Completed Results DMC FDA Device

• 1 other identifier: ABT-CIP-10305
• Study Type: interventional
• Target: 628
• Locations: 8 countries
• Sites: 49

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

Conditions

Heart Failure

Keywords

heart failure; ventricular assist device; LVAD; aspirin

Outcome Measures

Primary Outcomes (1)

• Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events

  The primary end point was a composite of survival free of non-surgical major hemocompatibility related adverse events (specifically stroke, pump thrombosis, major non-surgical bleeding, and arterial peripheral thromboembolism) at 1-year post implant.

  12 Months

Secondary Outcomes (6)

• Rates of Non-surgical Major Hemorrhagic Events

  Through Study Completion with a Median Follow up of 14 Months

• Rates of Bleeding Events

  Through Study Completion with a Median Follow up of 14 Months

• Rates of Non-surgical Major Thrombotic Events

  Through Study Completion with a Median Follow up of 14 Months

• Rates of Stroke

  Through Study Completion with a Median Follow up of 14 Months

• Survival Rates

  24 Months

Other Outcomes (5)

• Rate of Rehospitalization

  Through Study Completion with a Median Follow up of 14 Months

• Economic Cost Implications - Total Estimated Cost for Bleeding Events (CMS Cost Basis)

  12 Months

• Economic Cost Implications - Average Cost Per Bleeding Event

  12 Months

Study Arms (2)

Placebo Arm

PLACEBO COMPARATOR

LVAD Patients on the placebo arm will be given placebo medication

Device: LVAD Implant; Drug: Placebo oral tablet

Active Arm

ACTIVE COMPARATOR

LVAD Patients on the active arm will be given 100mg Aspirin

Device: LVAD Implant; Drug: Aspirin 100mg

Interventions

LVAD Implant DEVICE

Subjects will undergo Heartmate 3 LVAD implant prior to randomization

Active Arm; Placebo Arm

Aspirin 100mg DRUG

Subjects will be randomized to either Placebo or Aspirin post implant.

Active Arm

Placebo oral tablet DRUG

Subjects will be randomized to either Placebo or Aspirin post implant

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (51)

Baptist Health Medical Center

Little Rock, Arkansas, 72205, United States

Location

University of California, San Diego

La Jolla, California, 92037, United States

Location

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

California Pacific Medical Center - Van Ness Campus

San Francisco, California, 94109, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Miami Transplant Institute - Jackson Memorial

Miami, Florida, 33136, United States

Location

AdventHealth Orlando

Orlando, Florida, 32804, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

St. Vincent Hospital

Indianapolis, Indiana, 46240, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, 55455, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

New York-Presbyterian/Columbia University Medical Center

New York, New York, 10032, United States

Location

Montefiore Medical Center - Moses Division

New York, New York, 10467, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

Providence Heart & Vascular Institute

Portland, Oregon, 97225, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Allegheny General Hospital - ASRI

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Baylor University Hospital

Dallas, Texas, 75246, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Aurora Medical Group

Milwaukee, Wisconsin, 53215, United States

Location

St. Vincent's Hospital, Sydney

Darlinghurst, New, 2010, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

AKH - Wien

Vienna, 1090, Austria

Location

University of Alberta Hospital

Edmonton, T6G 2B7, Canada

Location

IKEM Prague

Prague, Central Bohemia, 140 24, Czechia

Location

Hopital Haut Leveque

Pessac, 33600, France

Location

CHU Rangueil Toulouse

Toulouse, 31000, France

Location

Ospedale San Raffaele

Milan, Italy

Location

National Research Center for Cardiac Surgery

Astana, 10000, Kazakhstan

Location

Queen Elizabeth Hospital

Birmingham, B15 2GW, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 37950897 BACKGROUND

• 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.

  PMID: 39774588 BACKGROUND

• 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.

  PMID: 34142415 BACKGROUND

• Katz JN, Connors JM, Pagani FD, Jorde UP, Gustafsson F, Uriel N, Netuka I, Byku M, Anyanwu A, Keebler M, Nathan S, Selzman CH, Alexis JD, Sulemanjee N, Atluri P, D'Allesandro D, Porter S, Lee FS, Mehra MR; ARIES Investigators. Hemocompatibility Outcomes With Pharmacological Therapy Following LVAD Implantation: Insights From the ARIES-HM3 Trial. JACC Heart Fail. 2025 Nov 19:102769. doi: 10.1016/j.jchf.2025.102769. Online ahead of print.

  PMID: 41258850 DERIVED

• Pagani FD, Netuka I, Jorde UP, Katz JN, Gustafsson F, Connors JM, Uriel N, Soltesz EG, Ivak P, Bansal A, Bitar A, Vega JD, Goldstein D, Danter M, Pya Y, Ravichandran A, Conway J, Adler ED, Chung ES, Grinstein J, Dirckx N, Iravani B, Mehra MR. Concomitant Surgical Procedures and Aspirin Avoidance With Left Ventricular Assist Device Therapy. JACC Heart Fail. 2025 Jul;13(7):102411. doi: 10.1016/j.jchf.2025.01.017. Epub 2025 Apr 9.

  PMID: 40208135 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

We excluded patients with early surgical complications or those that required mechanical support devices in addition to the implanted LVAD, or when investigators deemed aspirin therapy necessary.

Results Point of Contact

• Title: Nourdine Chakouri, PhD
• Organization: Abbott

nourdine.chakouri@abbott.com

(925) 989-5982

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator, site, patient, CEC, and core lab are blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blinded, randomized 1:1, active arm versus placebo arm

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 28, 2019
• Study Start: July 14, 2020
• Primary Completion: August 10, 2023
• Study Completion: August 10, 2023
• Last Updated: March 27, 2025
• Results First Posted: March 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (41); FR (2); IT (1); AU (1); KA (1); GB (1); CA (1); CZ (1)