N/A N=628 Randomized Quadruple-blind Supportive Care

The ARIES HeartMate 3 Pump IDE Study

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT04069156 ↗

Enrolled (actual)

628

Serious AEs

73.2%

Results posted

Mar 2025

Primary outcome: Primary: Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events — 201; 186 Participants — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: LVAD Implant (Device); Aspirin 100mg (Drug); Placebo oral tablet (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Abbott Medical Devices
Primary completion: Aug 2023

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	—

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

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.

View full record on ClinicalTrials.gov →

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.