Status:
COMPLETED
The ARIES HeartMate 3 Pump IDE Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 antagon...
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: v...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2023
Estimated Enrollment :
628 Patients enrolled
Trial Details
Trial ID
NCT04069156
Start Date
July 14 2020
End Date
August 10 2023
Last Update
March 27 2025
Active Locations (51)
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1
Baptist Health Medical Center
Little Rock, Arkansas, United States, 72205
2
University of California, San Diego
La Jolla, California, United States, 92037
3
Stanford University Medical Center
Palo Alto, California, United States, 94304
4
Sharp Memorial Hospital
San Diego, California, United States, 92123