The ARIES HeartMate 3 Pump IDE Study
Purpose
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
Condition
- Heart Failure
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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. 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
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Double-blinded, randomized 1:1, active arm versus placebo arm
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Investigator, site, patient, CEC, and core lab are blinded.
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Placebo Comparator Placebo Arm |
LVAD Patients on the placebo arm will be given placebo medication |
|
Active Comparator Active Arm |
LVAD Patients on the active arm will be given 100mg Aspirin |
|
More Details
- Status
- Completed
- Sponsor
- Abbott Medical Devices
Study Contact
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: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo.