HeartMate 3 CE Mark Study Long Term Follow-up (HM3 CE LTFU)

Abbott

Status: Completed

Conditions: Advanced Refractory Left Ventricular Heart Failure

Treatments: Other: Long term follow-up

Study type: Observational

Funder types: Industry

Identifiers

NCT03022461

HeartMate 3 CE Mark Study LTFU

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient or legal representative has signed Informed Consent Form (ICF).
2. 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

1. Patient does not consent to the continued data collection.

Trial design

25 participants in 1 patient group

Ongoing HM3 CE Mark study patients

Description:

The study will include the ongoing HM3 CE Mark study patients that have consented to continue the long term follow-up data collection.

Treatment:

Other: Long term follow-up