• EuroIntervention · Mar 2015

    Randomized Controlled Trial Multicenter Study Comparative Study

    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.

    • Jean-François Obadia, Xavier Armoiry, Bernard Iung, Thierry Lefèvre, Nathan Mewton, David Messika-Zeitoun, Bertrand Cormier, Julien Berthiller, Delphine Maucort-Boulch, Florent Boutitie, Bernadette Vaz, Jean-Noël Trochu, and Alec Vahanian.
    • Service de Chirurgie Cardiothoracique et Transplantation, Hôpital Cardiothoracique Louis Pradel, Lyon-Bron, France.
    • EuroIntervention. 2015 Mar 1; 10 (11): 1354-60.

    AimsPercutaneous 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 ResultsThe 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 randomisationConclusionsMITRA-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.

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