The ARIES HeartMate 3 Pump IDE Study

Abbott

Status: Completed

Conditions: Heart Failure

Treatments: Drug: Placebo oral tablet; Device: LVAD Implant; Drug: Aspirin 100mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04069156

ABT-CIP-10305

Details and patient eligibility

About

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

Full 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.

Enrollment: 628 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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628 participants in 2 patient groups, including a placebo group

Placebo Arm

Placebo Comparator group

Description:

LVAD Patients on the placebo arm will be given placebo medication

Treatment:

Device: LVAD Implant

Drug: Placebo oral tablet

Active Arm

Active Comparator group

Description:

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

Treatment:

Drug: Aspirin 100mg

Device: LVAD Implant