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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 : Completed
First Posted : August 28, 2019
Last Update Posted : December 15, 2023
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE August 21, 2019
First Posted Date  ICMJE August 28, 2019
Last Update Posted Date December 15, 2023
Actual Study Start Date  ICMJE July 14, 2020
Actual Primary Completion Date August 10, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2021)		 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
Original Primary Outcome Measures  ICMJE
 (submitted: August 23, 2019)		 Non-inferority 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2021)
  • 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.
  • 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.
  • Rate of Survival [ Time Frame: Up to 3 years post implant ]
    Survival will be compared between the two arms of the study.
  • Rate of Stroke Rates [ Time Frame: Up to 3 years post implant ]
    Stroke rates will be compared between the two arms of the study.
  • 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.
  • Rate of Bleeding Rates [ Time Frame: Up to 3 years post implant ]
    Bleeding rates will be compared between the two arms of the study.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2019)
  • Non-Surgical Bleeding Secondary Endpoint [ Time Frame: Up to 3 years post implant ]
    The non-surgical bleeding rate per patient year will be compared between treatment groups in the Primary Endpoint Population using Poisson regression.
  • Antiplatelet Therapy Removal Safety Endpoint [ Time Frame: Up to 3 years post implant ]
    To assess the safety of removal of antiplatelet therapy from the antithrombotic regimen between the two arms of the study using all patient follow up
Current Other Pre-specified Outcome Measures
 (submitted: February 1, 2021)
  • 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
  • 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
  • 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
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The ARIES HeartMate 3 Pump IDE Study
Official Title  ICMJE Antiplatelet Removal and HemocompatIbility EventS With the HeartMate 3 Pump IDE Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • 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.
  • Drug: Placebo oral tablet
    Subjects will be randomized to either Placebo or Aspirin post implant
Study Arms  ICMJE
  • Placebo Comparator: Placebo Arm
    LVAD Patients on the placebo arm will be given placebo medication
    Interventions:
    • Device: LVAD Implant
    • Drug: Placebo oral tablet
  • Active Comparator: Active Arm
    LVAD Patients on the active arm will be given 100mg Aspirin
    Interventions:
    • Device: LVAD Implant
    • Drug: Aspirin 100mg
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 23, 2019)		 628
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 10, 2023
Actual Primary Completion Date August 10, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Canada,   Czechia,   France,   Italy,   Kazakhstan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04069156
Other Study ID Numbers  ICMJE ABT-CIP-10305
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: To be determined
Current Responsible Party Abbott Medical Devices
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Abbott Medical Devices
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Abbott Medical Devices
Verification Date December 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP