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The ARIES HeartMate 3 Pump IDE Study

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04069156
Collaborator
(none)
628
Enrollment
51
Locations
2
Arms
36.5
Anticipated Duration (Months)
12.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: LVAD Implant
  • Drug: Aspirin 100mg
  • Drug: Placebo oral tablet
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
628 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double-blinded, randomized 1:1, active arm versus placebo armDouble-blinded, randomized 1:1, active arm versus placebo arm
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Investigator, site, patient, CEC, and core lab are blinded.
Primary Purpose:
Supportive Care
Official Title:
Antiplatelet Removal and HemocompatIbility EventS With the HeartMate 3 Pump IDE Study
Actual Study Start Date :
Jul 14, 2020
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Non-Inferiority Primary Endpoint [1 year post implant]

    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

Secondary Outcome Measures

  1. Rate of Non-surgical Major Hemorrhagic Events [Up to 3 years post implant]

    The non-surgical major hemorrhagic events will be compared between the two arms of the study.

  2. Rate of Non-surgical Major Thrombotic Events [Up to 3 years post implant]

    The non-surgical major thrombotic events will be compared between the two arms of the study.

  3. Rate of Survival [Up to 3 years post implant]

    Survival will be compared between the two arms of the study.

  4. Rate of Stroke Rates [Up to 3 years post implant]

    Stroke rates will be compared between the two arms of the study.

  5. Rate of Pump Thrombosis Rates [Up to 3 years post implant]

    Pump thrombosis rates will be compared between the two arms of the study.

  6. Rate of Bleeding Rates [Up to 3 years post implant]

    Bleeding rates will be compared between the two arms of the study.

Other Outcome Measures

  1. The Hemocompatibility Score (HCS) [Up to 3 years post implant]

    This study will also assess changes in the hemocompatibility score as a result of removal of antiplatelet therapy from the antithrombotic regimen

  2. Rate of Rehospitalization [Up to 3 years post implant]

    This study will also assess changes in the rehospitalization as a result of removal of antiplatelet therapy from the antithrombotic regimen

  3. Economic Cost Implications [Up to 3 years post implant]

    This study will also assess changes in the cost implications as a result of removal of antiplatelet therapy from the antithrombotic regimen

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baptist Health Medical Center Little Rock Arkansas United States 72205
2 University of California, San Diego La Jolla California United States 92037
3 Stanford University Medical Center Palo Alto California United States 94304
4 Sharp Memorial Hospital San Diego California United States 92123
5 California Pacific Medical Center - Van Ness Campus San Francisco California United States 94109
6 University of Colorado Hospital Aurora Colorado United States 80045
7 Washington Hospital Center Washington District of Columbia United States 20010
8 Miami Transplant Institute - Jackson Memorial Miami Florida United States 33136
9 AdventHealth Orlando Orlando Florida United States 32804
10 Piedmont Heart Institute Atlanta Georgia United States 30309
11 Emory University Hospital Atlanta Georgia United States 30322
12 University of Chicago Chicago Illinois United States 60637
13 Advocate Christ Medical Center Oak Lawn Illinois United States 60453
14 St. Vincent Hospital Indianapolis Indiana United States 46240
15 Kansas University Medical Center Kansas City Kansas United States 66160
16 Ochsner Medical Center New Orleans Louisiana United States 70121
17 Massachusetts General Hospital Boston Massachusetts United States 02114
18 Brigham & Women's Hospital Boston Massachusetts United States 02115
19 University of Michigan Ann Arbor Michigan United States 48109
20 Henry Ford Hospital Detroit Michigan United States 48202
21 Minneapolis Heart Institute Minneapolis Minnesota United States 55407
22 University of Minnesota Medical Center Fairview Minneapolis Minnesota United States 55455
23 Mount Sinai Hospital New York New York United States 10029
24 New York-Presbyterian/Columbia University Medical Center New York New York United States 10032
25 Montefiore Medical Center - Moses Division New York New York United States 10467
26 University of Rochester Medical Center Rochester New York United States 14642
27 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27599
28 Carolinas Medical Center Charlotte North Carolina United States 28203
29 Duke University Medical Center Durham North Carolina United States 27710
30 The Christ Hospital Cincinnati Ohio United States 45219
31 The Cleveland Clinic Foundation Cleveland Ohio United States 44195
32 Integris Baptist Medical Center Oklahoma City Oklahoma United States 73112
33 Providence Heart & Vascular Institute Portland Oregon United States 97225
34 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
35 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
36 Allegheny General Hospital - ASRI Pittsburgh Pennsylvania United States 15212
37 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
38 Baylor University Hospital Dallas Texas United States 75246
39 Memorial Hermann Hospital Houston Texas United States 77030
40 University of Utah Hospital Salt Lake City Utah United States 84132
41 Aurora Medical Group Milwaukee Wisconsin United States 53215
42 St. Vincent's Hospital, Sydney Darlinghurst New Australia 2010
43 The Alfred Hospital Melbourne Victoria Australia 3004
44 AKH - Wien Vienna Austria 1090
45 University of Alberta Hospital Edmonton Canada T6G 2B7
46 IKEM Prague Prague Central Bohemia Czechia 140 24
47 Hopital Haut Leveque Pessac France 33600
48 CHU Rangueil Toulouse Toulouse France 31000
49 Ospedale San Raffaele Milan Italy
50 National Research Center for Cardiac Surgery Astana Kazakhstan 10000
51 Queen Elizabeth Hospital Birmingham United Kingdom B15 2GW

Sponsors and Collaborators

  • Abbott Medical Devices

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT04069156
Other Study ID Numbers:
  • ABT-CIP-10305
First Posted:
Aug 28, 2019
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Abbott Medical Devices
heart failure
ventricular assist device
LVAD
aspirin
Additional relevant MeSH terms:
Heart Failure
Aspirin

Study Results

No Results Posted as of Jul 27, 2022