5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults

Medtentia International

Status: Completed

Conditions: Mitral Insufficiency; Mitral Regurgitation

Treatments: Device: Medtentia Annuloplasty Ring (MAR)

Study type: Observational

Funder types: Industry

Identifiers

NCT04161079

2010-040FU5

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

12 participants in 1 patient group

MAR population

Description:

Subjects, who underwent MV repair operation with successful MAR implantation in clinical investigation 2010-040

Treatment:

Device: Medtentia Annuloplasty Ring (MAR)