N/A
Completed N=628
The ARIES HeartMate 3 Pump IDE Study
Source: ClinicalTrials.gov NCT04069156 ↗Enrolled (actual)
628
Serious AEs
73.2%
Results posted
Mar 2025
Primary outcomePrimary: Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events — 201; 186 Participants — p=<0.0001
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events |
201; 186 | <0.0001 sig |
| SECONDARY Rates of Non-surgical Major Hemorrhagic Events |
26.2; 40.7; 25.93; 39.53; 0.27; 0.85 | — |
| SECONDARY Rates of Bleeding Events |
25.92; 39.53; 8.46; 13.65; 17.47; 25.88 | — |
| SECONDARY Rates of Non-surgical Major Thrombotic Events |
1.64; 2.84; 1.64; 2.56; 0.00; 0.00 | — |
| SECONDARY Rates of Stroke |
1.91; 3.70; 0.82; 0.57; 1.09; 3.13 | — |
| SECONDARY Survival Rates |
93; 89.7 | — |
| SECONDARY Risk of Non-Surgical Bleeding Events |
30.0; 42.4 | — |
Eligibility Criteria
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.
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04069156). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.