ARIES HM3

Brief Summary

Clinical Investigation Objective

To study the safety and efficacy of an anti-platelet-free antithrombotic regimen in patients with advanced heart failure treated with the HeartMate 3 (HM3) LVAS.

Hypothesis

Withdrawal of antiplatelet therapy from the antithrombotic regimen of HM3 pump patients will not adversely affect safety or efficacy of the HM3 and may reduce non-surgical bleeding.

Substudy in protocol, page 66: (APPENDIX VI: DEVICE POSITION SUBSTUDY PROTOCOL):

To develop and validate the use of a radiopaque surgical marker placed on the anterior surface of the aortic root below the sino-tubular ridge of the aorta just above the ostia of the right coronary artery to be used as a surrogate anatomical reference or landmark to more optimally assess HeartMate 3 inflow cannula position. Validation will be performed by assessing:

1. The safety and feasibility of placing and visualizing the radiopaque marker;

2. The variation in cannula angulation relative to the radiopaque marker and cannula positional changes over time;

3. The relationship between the initial cannula angulation or its change over time with adverse clinical outcomes and functional capacity, as an exploratory analysis.

Inclusion 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 patients of child bearing capability, subject will not be currently pregnant or breastfeeding and on appropriate contraception.

Substudy Inclusion criteria:

1. Subjects enrolled within the ARIES HM3 study.

Exclusion Criteria

Exclusion Criteria

1. Post-implant additional temporary or permanent mechanical circulatory support (MCS).
2. Post-implant 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.

Substudy Exclusion Criteria:

1. In the judgement of the implanting surgeon, that placement of the radiopaque

surgical marker would have unacceptable risk based upon technical reasons

or patient anatomy.

2. Subjects undergoing placement of the HeartMate 3 device through a

minimally-invasive approach where sternotomy or upper sternotomy will not be

performed and access to the anterior surface of the aorta below the sinotubular

ridge is not feasible.