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Completed

NCT Number: NCT04069156

The ARIES 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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Vincent's Hospital, Sydney, Darlinghurst, New, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LVAD implant

Device

Subjects will undergo Heartmate 3 LVAD implant prior to randomization

Aspirin 100mg

Drug

Subjects will be randomized to either Placebo or Aspirin post implant.

Placebo oral tablet

Drug

Subjects will be randomized to either Placebo or Aspirin post implant

Primary outcomes

  1. Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events

    Time frame: 12 Months

    The primary end point was a composite of survival free of non-surgical major hemocompatibility related adverse events (specifically stroke, pump thrombosis, major non-surgical bleeding, and arterial peripheral thromboembolism) at 1-year post implant.

Secondary outcomes

  1. Rates of Non-surgical Major Hemorrhagic Events

    Time frame: Through Study Completion with a Median Follow up of 14 Months

    The rate of non-surgical hemorrhagic events were compared between the two arms of the study. Non-surgical Major Hemorrhagic events: Hemorrhagic event rate per patient year was calculated by dividing all non-surgical bleeding events and hemorrhagic stroke events by the cumulative years of study exposure.

  2. Rates of Bleeding Events

    Time frame: Through Study Completion with a Median Follow up of 14 Months

    The bleeding rate was calculated by dividing the number of bleeding events by the cumulative duration of study exposure (years of support).

  3. Rates of Non-surgical Major Thrombotic Events

    Time frame: Through Study Completion with a Median Follow up of 14 Months

    The rates of non-surgical major thrombotic events was compared between the two arms of the study. The thrombotic event rate per patient year was calculated by dividing the number of non-surgical ischemic strokes, pump thrombosis and arterial peripheral thromboembolic events by the cumulative years of study exposure

  4. Rates of Stroke

    Time frame: Through Study Completion with a Median Follow up of 14 Months

    The stroke rate was calculated based on the number of strokes experienced by subjects, 14 days or more after device implant, and while on their treatment assignment, divided by the cumulative duration of study exposure (years of support).

  5. Survival Rates

    Time frame: 24 Months

    The overall survival rate was analyzed using a Kaplan-Meier analysis and the treatment groups were compared using log-rank test. Survival was calculated starting at 14 days post implant.

  6. Risk of Non-Surgical Bleeding Events

    Time frame: 24 Months

    Risk of non-surgical bleeding events was analyzed using a Kaplan-Meier analysis. The treatment groups were compared using a log-rank test.

Other outcomes

  1. Rate of Rehospitalization

    Time frame: Through Study Completion with a Median Follow up of 14 Months

    This study assessed changes in the rehospitalization as a result of removal of antiplatelet therapy from the antithrombotic regimen.

  2. Economic Cost Implications - Total Estimated Cost for Bleeding Events (CMS Cost Basis)

    Time frame: 12 Months

    Cost of bleeding episodes was calculated based on a previously published economic model, adjusted for inflation using the US Bureau of Labor Statistics Medical Consumer Price Index. To ensure uniformity in care practices and relevance of the previously published model, only US subjects were included.

  3. Economic Cost Implications - Average Cost Per Bleeding Event

    Time frame: 12 Months

    These values were derived by dividing the total estimated cost for bleeding events by the number of events to determine the average cost per bleeding event. Consequently, a measure of dispersion is not available for these outcomes.

  4. Economic Cost Implications - Average Cost Per Study Patient Over the First-year Post-implant

    Time frame: 12 Months

    These values were derived by dividing the total estimated cost for bleeding events by the number of patients to obtain the average cost per study patient. Consequently, a measure of dispersion is not available for these outcomes.

  5. Economic Cost Implications - Cost of Bleeding Hospitalization for 1000 LVAD Implants Over the First-year Post-implant

    Time frame: 12 Months

    Cost of bleeding episodes was calculated based on a previously published economic model, adjusted for inflation using the US Bureau of Labor Statistics Medical Consumer Price Index. To ensure uniformity in care practices and relevance of the previously published model, only US subjects were included.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Antiplatelet Removal and HemocompatIbility EventS With the HeartMate 3 Pump IDE Study

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 28, 2019
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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