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

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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

Trial documents
1

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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