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HeartMate 3 CE Mark Study Long Term Follow-up

NCT03022461 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2022-06-27

Study results available
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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.

Conditions

  • Advanced Refractory Left Ventricular Heart Failure

Interventions

OTHER

Long term follow-up

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Carlo Gazzola, B. Sc. · Abbott

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-23
Primary Completion
2019-12-12
Completion
2019-12-12

Countries

  • Australia
  • Austria
  • Canada
  • Czechia
  • Germany
  • Kazakhstan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03022461 on ClinicalTrials.gov