The ARIES HeartMate 3 Pump IDE Study

• Status: Recruiting
• Trial end date: 2023-07-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott Medical Devices
• Treatments: Aspirin

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.