N/A
N=12
5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults
Mitral Regurgitation · Mitral Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT04161079 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Safety: the Occurrence, Nature and Frequency of Significant Medical Events — 0 Events
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Medtentia Annuloplasty Ring (MAR) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtentia International Ltd Oy
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety: the Occurrence, Nature and Frequency of Significant Medical Events |
— | — |
| PRIMARY Performance: Change in Mitral Regurgitation (MR) as Measured by Trans-Thoracic Echocardiography (TTE) |
8; 5; 3; 2; 0; 0 | — |
| SECONDARY Safety: All-Cause Mortality |
1 | — |
| SECONDARY Safety: the Occurrence, Nature and Frequency of Adverse Device Effects (ADEs) and/or Device Deficiencies |
— | — |
| SECONDARY Safety: Number of Cardiovascular Admissions |
— | — |
| SECONDARY Safety: the Number of Subjects With Clinically Significant Abnormal Findings |
— | — |
| SECONDARY Performance: Change in Mitral Regurgitation Parameters (Left Ventricle Reverse Remodeling), as Measured by TTE |
38; 41; 51; 56 | — |
| SECONDARY Performance: Changes in New York Heart Association (NYHA) Classification When Compared to the Clinical Investigation 2010-040 2-year Follow-Up Visit |
11; 1; 0; 6; 0; 0 | — |
| SECONDARY Performance: Number of Subjects With Recurrence of Mitral Regurgitation |
— | — |
| SECONDARY Performance: Change in Mitral Regurgitation Parameters (Coaptation Height), as Measured by TTE |
7.4; 3.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Signed Informed Consent Form.
- Subject had a successful MAR implantation in clinical investigation 2010-040.
- Subject is willing to participate in the follow-up study and to comply with the requirements of the Clinical Investigation Plan.
Exclusion Criteria
- Subjects who participated in the clinical investigation 2010-040 but had the MAR replaced with another mitral valve repair ring or system.
Data sourced from ClinicalTrials.gov (NCT04161079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.