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The ARIES HeartMate 3 Pump IDE Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069156
Recruitment Status : Active, not recruiting
First Posted : August 28, 2019
Last Update Posted : May 11, 2023
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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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
Heart Failure Device: LVAD Implant Drug: Aspirin 100mg Drug: Placebo oral tablet Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 628 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-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 : July 14, 2020
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Aspirin

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Non-Inferiority Primary Endpoint [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 3 years post implant ]
    Survival will be compared between the two arms of the study.

  4. Rate of Stroke Rates [ Time Frame: Up to 3 years post implant ]
    Stroke rates will be compared between the two arms of the study.

  5. Rate of Pump Thrombosis Rates [ Time Frame: Up to 3 years post implant ]
    Pump thrombosis rates will be compared between the two arms of the study.

  6. Rate of Bleeding Rates [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069156


Locations
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Sponsors and Collaborators
Abbott Medical Devices
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT04069156    
Other Study ID Numbers: ABT-CIP-10305
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: May 11, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: To be determined

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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:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics