The ARIES HeartMate 3 Pump IDE Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Device: LVAD Implant
* Drug: Aspirin 100mg
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blinded, randomized 1:1, active arm versus placebo arm
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Arm<br>LVAD Patients on the placebo arm will be given placebo medication | Device: LVAD Implant<br>* Subjects will undergo Heartmate 3 LVAD implant prior to randomization<br>Drug: Placebo oral tablet<br>* Subjects will be randomized to either Placebo or Aspirin post implant<br>|
| Active Comparator: Active Arm<br>LVAD Patients on the active arm will be given 100mg Aspirin | Device: LVAD Implant<br>* Subjects will undergo Heartmate 3 LVAD implant prior to randomization<br>Drug: Aspirin 100mg<br>* Subjects will be randomized to either Placebo or Aspirin post implant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year post implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Non-surgical Major Hemorrhagic Events | The non-surgical major hemorrhagic events will be compared between the two arms of the study. | Up to 3 years post implant | 
| Rate of Non-surgical Major Thrombotic Events | The non-surgical major thrombotic events will be compared between the two arms of the study. | Up to 3 years post implant | 
| Rate of Survival | Survival will be compared between the two arms of the study. | Up to 3 years post implant | 
| Rate of Stroke Rates | Stroke rates will be compared between the two arms of the study. | Up to 3 years post implant | 
| Rate of Pump Thrombosis Rates | Pump thrombosis rates will be compared between the two arms of the study. | Up to 3 years post implant | 
| Rate of Bleeding Rates | Bleeding rates will be compared between the two arms of the study. | Up to 3 years post implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LVAD, heart failure, ventricular assist device, aspirin