At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
HeartMate 3 CE Mark Study Long Term Follow-up Clinical Investigation Plan
In Brief
An observational study evaluating Long term follow-up for Advanced Refractory Left Ventricular Heart Failure. Completed, enrolled 25 participants across 8 sites in 6 countries.
Detailed 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.