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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

1. Service de Chirurgie Cardiothoracique et Transplantation, Hôpital Cardiothoracique Louis Pradel, Lyon-Bron, France; 2. INSERM, U 886 “Cardioprotection”, Laboratoire de Physiologie Lyon Nord, UCBL1, Lyon, France; 3. Hospices Civils de Lyon, DRCI, Cellule Innovation, Lyon, France; 4. Université Claude Bernard Lyon 1, UMR-CNRS 5510/MATEIS, Lyon, France; 5. Département de Cardiologie, Hôpital Xavier Bichat, Faculté Paris Diderot, DHU FIRE, Paris, France; 6. Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France; 7. Hôpital Cardiovasculaire Louis Pradel, Clinical Investigation Center, INSERM 1407, Hospices Civils de Lyon, Bron, France; 8. Hospices Civils de Lyon, Service de Biostatistique, Lyon, France; Université Lyon I, Villeurbanne, France; CNRS; UMR 5558, Laboratoire Biostatistique Santé, Pierre-Bénite, France; 9. L’Institut du Thorax, Clinique Cardiologique, Hôpital Guillaume et René Laennec, Nantes, France

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.

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