Trials / Completed
CompletedNCT03022461
HeartMate 3 CE Mark Study Long Term Follow-up
HeartMate 3 CE Mark Study Long Term Follow-up Clinical Investigation Plan
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 25 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Long term follow-up |
Timeline
- Start date
- 2014-06-23
- Primary completion
- 2019-12-12
- Completion
- 2019-12-12
- First posted
- 2017-01-16
- Last updated
- 2022-06-27
- Results posted
- 2021-12-02
Locations
8 sites across 6 countries: Australia, Austria, Canada, Czechia, Germany, Kazakhstan
Source: ClinicalTrials.gov record NCT03022461. Inclusion in this directory is not an endorsement.