EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2015
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.
Сравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Obadia Jean-François, Armoiry Xavier, Iung Bernard, Lefèvre Thierry, Mewton Nathan, Messika-Zeitoun David, Cormier Bertrand, Berthiller Julien, Maucort-Boulch Delphine, Boutitie Florent, Vaz Bernadette, Trochu Jean-Noël, Vahanian Alec
Аннотация
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.
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.