N/A Completed N=25

HeartMate 3 CE Mark Study Long Term Follow-up

Advanced Refractory Left Ventricular Heart Failure

Source: ClinicalTrials.gov NCT03022461 ↗

Enrolled (actual)

Serious AEs

52.0%

Results posted

Dec 2021

Primary outcomePrimary: Survival — 61 percentage of patients who survived

Summary

The purpose of this clinical investigation is to report the long term survival and incidence of adverse events in the patients who were implanted with HM3 in the CE Mark Study and continue to be ongoing with the HeartMate 3 LVAS after the CE Mark Study 2 year follow-up. The study will be a single arm, prospective, multi-center, non-blinded and non-randomized study, intended to report on the long term use of the HeartMate 3 LVAS in those patients that completed the 2-year follow-up in the HeartMate 3 CE Mark study.

Outcome Measures

Outcome	Result	p-value
PRIMARY Survival	61	—
SECONDARY EuroQoL 5D-5L (EQ-5D-5L) VAS Score	69.3	—
SECONDARY Six Minute Walk Test (6MWT)	294.4	—
SECONDARY New York Heart Association (NYHA)	9; 10; 2; 0; 0	—
SECONDARY Adverse Events	3; 9; 2; 3; 0; 0	—
SECONDARY Device Malfunctions	—	—
SECONDARY Reoperations	1; 6; 4; 11	—
SECONDARY Rehospitalizations	1; 19; 2; 2; 1; 0	—
SECONDARY Percentage of Participants Who Survived Without Experiencing a Debilitating Stroke (MRS>3)	55.1; 61.0	—

Eligibility Criteria

Inclusion Criteria

Patient or legal representative has signed Informed Consent Form (ICF).
Patient was enrolled in the HeartMate 3 CE Mark Study and continues to be supported with the HeartMate 3 LVAS after the 2 year CE Mark study follow-up.

Exclusion Criteria

Patient does not consent to the continued data collection.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03022461). 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.