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Study on Safety and Performance of Medtentia Mitral Valve Repair System in Surgical Repair of Mitral Regurgitation

Mitral Regurgitation Clinical Trial

Official title:
Evaluation of the Safety and Performance of the Medtentia Mitral Valve Repair System When Used in Adults Undergoing Mitral Valve Repair Surgery

Clinical Trial Summary

The purpose of the trial is to demonstrate the safety and performance of the Medtentia Annuloplasty Ring (MAR) during mitral valve repair surgery. In addition, the trial aims to demonstrate that the MAR fulfills the requirements for mitral valve annuloplasty rings.

Clinical Trial Description

The purpose of this study is to evaluate the safety and performance of the MAR in patients with mitral regurgitation requiring either isolated mitral valve annuloplasty or mitral valve annuloplasty concomitantly with any of the following, either individually or in combination:

- Tricuspid valve repair

- Coronary artery bypass grafting (CABG)

- Valve resection and chordae repair

- Correction of atrial septal defect

- Correction of patent foramen ovale

- Ablation therapy for atrial defibrillation ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01678144
Study type Interventional
Source Medtentia International Ltd Oy
Contact
Status Terminated
Phase N/A
Start date June 30, 2011
Completion date April 22, 2016
View Details
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