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The ARIES HeartMate 3 Pump IDE Study

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
LVAD Implant
Aspirin 100mg
Placebo oral tablet
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring heart failure, ventricular assist device, LVAD, aspirin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Baptist Health Medical Center
  • University of California, San Diego
  • Stanford University Medical Center
  • Sharp Memorial Hospital
  • California Pacific Medical Center - Van Ness Campus
  • University of Colorado Hospital
  • Washington Hospital Center
  • Miami Transplant Institute - Jackson Memorial
  • AdventHealth Orlando
  • Piedmont Heart Institute
  • Emory University Hospital
  • University of Chicago
  • Advocate Christ Medical Center
  • St. Vincent Hospital
  • Kansas University Medical Center
  • Ochsner Medical Center
  • Massachusetts General Hospital
  • Brigham & Women's Hospital
  • University of Michigan
  • Henry Ford Hospital
  • Minneapolis Heart Institute
  • University of Minnesota Medical Center Fairview
  • Mount Sinai Hospital
  • New York-Presbyterian/Columbia University Medical Center
  • Montefiore Medical Center - Moses Division
  • University of Rochester Medical Center
  • University of North Carolina at Chapel Hill
  • Carolinas Medical Center
  • Duke University Medical Center
  • The Christ Hospital
  • The Cleveland Clinic Foundation
  • Integris Baptist Medical Center
  • Providence Heart & Vascular Institute
  • Hospital of the University of Pennsylvania
  • Thomas Jefferson University Hospital
  • Allegheny General Hospital - ASRI
  • University of Pittsburgh Medical Center
  • Baylor University Hospital
  • Memorial Hermann Hospital
  • University of Utah Hospital
  • Aurora Medical Group
  • St. Vincent's Hospital, Sydney
  • The Alfred Hospital
  • AKH - Wien
  • University of Alberta Hospital
  • IKEM Prague
  • Hopital Haut Leveque
  • CHU Rangueil Toulouse
  • Ospedale San Raffaele
  • National Research Center for Cardiac Surgery
  • Queen Elizabeth Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo Arm

Active Arm

Arm Description

LVAD Patients on the placebo arm will be given placebo medication

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of Non-surgical Major Hemorrhagic Events
The non-surgical major hemorrhagic events will be compared between the two arms of the study.
Rate of Non-surgical Major Thrombotic Events
The non-surgical major thrombotic events will be compared between the two arms of the study.
Rate of Survival
Survival will be compared between the two arms of the study.
Rate of Stroke Rates
Stroke rates will be compared between the two arms of the study.
Rate of Pump Thrombosis Rates
Pump thrombosis rates will be compared between the two arms of the study.
Rate of Bleeding Rates
Bleeding rates will be compared between the two arms of the study.

Full Information

First Posted
August 21, 2019
Last Updated
August 23, 2023
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT04069156
Brief Title
The ARIES HeartMate 3 Pump IDE Study
Official Title
Antiplatelet Removal and HemocompatIbility EventS With the HeartMate 3 Pump IDE Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 14, 2020 (Actual)
Primary Completion Date
August 10, 2023 (Actual)
Study Completion Date
August 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

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
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, ventricular assist device, LVAD, aspirin

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blinded, randomized 1:1, active arm versus placebo arm
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Investigator, site, patient, CEC, and core lab are blinded.
Allocation
Randomized
Enrollment
628 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
LVAD Patients on the placebo arm will be given placebo medication
Arm Title
Active Arm
Arm Type
Active Comparator
Arm Description
LVAD Patients on the active arm will be given 100mg Aspirin
Intervention Type
Device
Intervention Name(s)
LVAD Implant
Intervention Description
Subjects will undergo Heartmate 3 LVAD implant prior to randomization
Intervention Type
Drug
Intervention Name(s)
Aspirin 100mg
Intervention Description
Subjects will be randomized to either Placebo or Aspirin post implant.
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
Subjects will be randomized to either Placebo or Aspirin post implant
Primary Outcome Measure Information:
Title
Non-Inferiority Primary Endpoint
Description
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
Time Frame
1 year post implant
Secondary Outcome Measure Information:
Title
Rate of Non-surgical Major Hemorrhagic Events
Description
The non-surgical major hemorrhagic events will be compared between the two arms of the study.
Time Frame
Up to 3 years post implant
Title
Rate of Non-surgical Major Thrombotic Events
Description
The non-surgical major thrombotic events will be compared between the two arms of the study.
Time Frame
Up to 3 years post implant
Title
Rate of Survival
Description
Survival will be compared between the two arms of the study.
Time Frame
Up to 3 years post implant
Title
Rate of Stroke Rates
Description
Stroke rates will be compared between the two arms of the study.
Time Frame
Up to 3 years post implant
Title
Rate of Pump Thrombosis Rates
Description
Pump thrombosis rates will be compared between the two arms of the study.
Time Frame
Up to 3 years post implant
Title
Rate of Bleeding Rates
Description
Bleeding rates will be compared between the two arms of the study.
Time Frame
Up to 3 years post implant
Other Pre-specified Outcome Measures:
Title
The Hemocompatibility Score (HCS)
Description
This study will also assess changes in the hemocompatibility score as a result of removal of antiplatelet therapy from the antithrombotic regimen
Time Frame
Up to 3 years post implant
Title
Rate of Rehospitalization
Description
This study will also assess changes in the rehospitalization as a result of removal of antiplatelet therapy from the antithrombotic regimen
Time Frame
Up to 3 years post implant
Title
Economic Cost Implications
Description
This study will also assess changes in the cost implications as a result of removal of antiplatelet therapy from the antithrombotic regimen
Time Frame
Up to 3 years post implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Baptist Health Medical Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
California Pacific Medical Center - Van Ness Campus
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Miami Transplant Institute - Jackson Memorial
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
St. Vincent Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46240
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Minneapolis Heart Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
University of Minnesota Medical Center Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
New York-Presbyterian/Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Montefiore Medical Center - Moses Division
City
New York
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Integris Baptist Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Providence Heart & Vascular Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Allegheny General Hospital - ASRI
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Baylor University Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Aurora Medical Group
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
St. Vincent's Hospital, Sydney
City
Darlinghurst
State/Province
New
ZIP/Postal Code
2010
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
AKH - Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
University of Alberta Hospital
City
Edmonton
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
IKEM Prague
City
Prague
State/Province
Central Bohemia
ZIP/Postal Code
140 24
Country
Czechia
Facility Name
Hopital Haut Leveque
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
CHU Rangueil Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
Ospedale San Raffaele
City
Milan
Country
Italy
Facility Name
National Research Center for Cardiac Surgery
City
Astana
ZIP/Postal Code
10000
Country
Kazakhstan
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2GW
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
To be determined
Citations:
PubMed Identifier
34142415
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.
Results Reference
derived

Learn more about this trial

The ARIES HeartMate 3 Pump IDE Study

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