The MITRA-FR study: Design and rationale of a randomised study of percutaneous mitral valve repair compared with optimal medical management alone for severe secondary mitral regurgitation
Résumé
Aims: Percutaneous mitral valve repair (pMVR) is a new therapeutic option for mitral valve regurgitation. Positive preliminary results in non-randomised studies have been published supporting the use of the MitraClip system in patients with secondary mitral regurgitation (MR) and poor left ventricular (LV) function contraindicated to surgery. The aim of the MITRA-FR study is to provide a higher level of evidence for the efficacy of the MitraClip device in this setting. Methods and results: The MITRA-FR study is a national, multicentre, investigator-initiated, open-label, randomised trial to evaluate the benefits and safety of pMVR using the MitraClip system plus optimal medical therapy (OMT) compared with OMT alone (control) in patients with severe symptomatic secondary MR contraindicated to surgical repair. The trial aims to enrol 144 MitraClip-treated subjects and 144 control (OMT alone) patients. The primary endpoint is a composite of all-cause mortality and unplanned hospitalisations for heart failure at 12 months after randomisation. Conclusions: MITRA-FR is a randomised controlled national trial designed to evaluate the performance of pMVR in comparison to OMT in patients with severe symptomatic secondary MR contraindicated to cardiac surgery. © Europa Digital & Publishing 2015. All rights reserved.
Mots clés
Mitral Valve Annuloplasty
Severity of Illness Index
Treatment Outcome
Article
cardiovascular procedure
cohort analysis
device safety
controlled study
heart failure
human
hospitalization
implantable clip
cardiovascular agent
complication
heart catheterization
80 and over
Cardiovascular Agents
Cardiac Catheterization
major clinical study
Aged
mitral valve regurgitation
mitral valve repair
multicenter study
mortality
open study
optimal medical therapy
prospective study
randomized controlled trial
Cardiomyopathy
Mitral Valve Insufficiency
very elderly
procedures
intermethod comparison
mitral annuloplasty
comparative study
clinical trial
Dilated
Male
Humans
Female
Disease Management