The ARIES HeartMate 3 Pump IDE Study

Antiplatelet Removal and HemocompatIbility EventS With the 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

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: LVAD Implant; Drug: Placebo oral tablet; Drug: Aspirin 100mg

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.

• Study Type: Interventional
• Enrollment (Actual): 628
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New
    • Darlinghurst, New, Australia, 2010
      • St. Vincent's Hospital, Sydney
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
• Austria
  • Vienna, Austria, 1090
    • AKH - Wien
• Canada
  • Edmonton, Canada, T6G 2B7
    • University of Alberta Hospital
• Czechia
  • Central Bohemia
    • Prague, Central Bohemia, Czechia, 140 24
      • IKEM Prague
• France
  • Pessac, France, 33600
    • Hôpital Haut Lévêque
  • Toulouse, France, 31000
    • CHU Rangueil Toulouse
• Italy
  • Milan, Italy
    • Ospedale San Raffaele
• Kazakhstan
  • Astana, Kazakhstan, 10000
    • National Research Center for Cardiac Surgery
• United Kingdom
  • Birmingham, United Kingdom, B15 2GW
    • Queen Elizabeth Hospital
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Baptist Health Medical Center
  • California
    • La Jolla, California, United States, 92037
      • University of California, San Diego
    • Palo Alto, California, United States, 94304
      • Stanford University Medical Center
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital
    • San Francisco, California, United States, 94109
      • California Pacific Medical Center - Van Ness Campus
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Miami, Florida, United States, 33136
      • Miami Transplant Institute - Jackson Memorial
    • Orlando, Florida, United States, 32804
      • AdventHealth Orlando
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46240
      • St. Vincent Hospital
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center Fairview
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • New York, New York, United States, 10032
      • New York-Presbyterian/Columbia University Medical Center
    • New York, New York, United States, 10467
      • Montefiore Medical Center - Moses Division
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • INTEGRIS Baptist Medical Center
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Heart & Vascular Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital - ASRI
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Hospital
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Arm; LVAD Patients on the placebo arm will be given placebo medication	Device: LVAD Implant; Subjects will undergo Heartmate 3 LVAD implant prior to randomization; Drug: Placebo oral tablet; Subjects will be randomized to either Placebo or Aspirin post implant
Active Comparator: Active Arm; LVAD Patients on the active arm will be given 100mg Aspirin	Device: LVAD Implant; Subjects will undergo Heartmate 3 LVAD implant prior to randomization; Drug: Aspirin 100mg; Subjects will be randomized to either Placebo or Aspirin post implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-Inferiority Primary Endpoint	The primary endpoint for this study will be met if the placebo arm is non-inferior to the aspirin arm in the composite of survival free of any non-surgical (any event occuring > 14 days post implant) major hemocompatibility related adverse event (Stroke, pump thrombosis, bleeding [intracranial bleeds that do not meet stroke definition], arterial peripheral thromboembolism), at 1-year post implant	1 year post implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Non-surgical Major Hemorrhagic Events	The non-surgical major hemorrhagic events will be compared between the two arms of the study.	Up to 3 years post implant
Rate of Non-surgical Major Thrombotic Events	The non-surgical major thrombotic events will be compared between the two arms of the study.	Up to 3 years post implant
Rate of Survival	Survival will be compared between the two arms of the study.	Up to 3 years post implant
Rate of Stroke Rates	Stroke rates will be compared between the two arms of the study.	Up to 3 years post implant
Rate of Pump Thrombosis Rates	Pump thrombosis rates will be compared between the two arms of the study.	Up to 3 years post implant
Rate of Bleeding Rates	Bleeding rates will be compared between the two arms of the study.	Up to 3 years post implant

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Hemocompatibility Score (HCS)	This study will also assess changes in the hemocompatibility score as a result of removal of antiplatelet therapy from the antithrombotic regimen	Up to 3 years post implant
Rate of Rehospitalization	This study will also assess changes in the rehospitalization as a result of removal of antiplatelet therapy from the antithrombotic regimen	Up to 3 years post implant
Economic Cost Implications	This study will also assess changes in the cost implications as a result of removal of antiplatelet therapy from the antithrombotic regimen	Up to 3 years post implant

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2020
• Primary Completion (Actual): August 10, 2023
• Study Completion (Actual): August 10, 2023

Study Registration Dates

• First Submitted: August 21, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: heart failure; aspirin; LVAD; ventricular assist device
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: ABT-CIP-10305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To be determined

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes