Trials / Completed
CompletedNCT04161079
5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults
Evaluation of the 5-Year Safety and Performance of the Medtentia Annuloplasty Ring in Adults - Follow-Up to Clinical Investigation 2010-040
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 12 (actual)
- Sponsor
- Medtentia International Ltd Oy · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
Single-center clinical investigation is to evaluate long-term safety and performance of the Medtentia Annuloplasty Ring (MAR) in 11 patients who underwent successful mitral valve (MV) surgery using Medtentia's MAR system in clinical investigation 2010-040 performed during June 2011 - April 2016.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Medtentia Annuloplasty Ring (MAR) | Mitral valve repair using the MAR performed in clinical investigation 2010-040 |
Timeline
- Start date
- 2019-11-08
- Primary completion
- 2020-01-29
- Completion
- 2020-01-29
- First posted
- 2019-11-13
- Last updated
- 2020-09-28
- Results posted
- 2020-09-28
Locations
1 site across 1 country: Finland
Source: ClinicalTrials.gov record NCT04161079. Inclusion in this directory is not an endorsement.