At a glance
ClinicalIndex Comparison RecordN/ACompleted· 12 enrolled
Drug / intervention
Medtentia Annuloplasty Ring (MAR)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of the 5-Year Safety and Performance of the Medtentia Annuloplasty Ring in Adults - Follow-Up to Clinical Investigation 2010-040
In Brief
An observational study evaluating Medtentia Annuloplasty Ring (MAR) for Mitral Regurgitation and Mitral Insufficiency. Completed, enrolled 12 participants across 1 site.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsMitral Regurgitation, Mitral Insufficiency
CountriesFinland
Collaborators--
Timeline
N/ACompletedFinished
2020202120222023202420252026
Enrollment StartNov 2019
First PostedNov 2019
Primary CompletionJan 2020
TodayJul 2026
First PostedNov 13, 2019
Enrollment StartNov 8, 2019
Primary CompletionJan 29, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.6 years ago
Interventions
Medtentia Annuloplasty Ring (MAR)device
Mitral valve repair using the MAR performed in clinical investigation 2010-040