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

EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
Jean-François ObadiaAlec Vahanian

Abstract

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. 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 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.

References

Apr 12, 2005·The Journal of Thoracic and Cardiovascular Surgery·Donald D GlowerJ Scott Rankin
May 28, 2005·European Journal of Heart Failure·Giovanni CioffiCristina Opasich
Jun 5, 2007·Journal of the American College of Cardiology·Tomislav MihaljevicBruce W Lytle
Mar 20, 2010·European Heart Journal·Corrado TamburinoOttavio Alfieri
May 4, 2010·European Journal of Echocardiography : the Journal of the Working Group on Echocardiography of the European Society of Cardiology·Patrizio LancellottiUNKNOWN European Association of Echocardiography
Apr 6, 2011·The New England Journal of Medicine·Ted FeldmanUNKNOWN EVEREST II Investigators
Jun 12, 2012·European Journal of Heart Failure·Stephan BaldusUNKNOWN German Transcatheter Mitral Valve Interventions (TRAMI) investigators
Aug 28, 2012·European Heart Journal·UNKNOWN Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC)Marian Zembala
Sep 11, 2012·Archives of Cardiovascular Diseases·Jean-Francois ObadiaFrancesco Maisano
May 15, 2013·Journal of the American College of Cardiology·Laura MauriUNKNOWN EVEREST II Investigators
Jun 19, 2013·Archives of Cardiovascular Diseases·Xavier ArmoiryJean-François Obadia
Dec 11, 2013·Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions·Kairav VakilSelcuk Adabag
Mar 4, 2014·Journal of the American College of Cardiology·Ted Feldman, Amelia Young
Jul 12, 2014·Journal of the American College of Cardiology·Donald D GlowerTed Feldman
Aug 30, 2014·Journal of the American College of Cardiology·Georg NickenigUNKNOWN Transcatheter Valve Treatment Sentinel Registry Investigators of the EURObservational Research Programme of the European Soc

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Citations

Jan 5, 2016·European Heart Journal·Bernard IungAlec Vahanian
Mar 31, 2016·Lancet·Rick A NishimuraMichael J Mack
Oct 19, 2017·European Journal of Heart Failure·Francesco Maisano, Frank Ruschitzka
Aug 28, 2018·The New England Journal of Medicine·Jean-François ObadiaUNKNOWN MITRA-FR Investigators
Aug 31, 2018·EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology·Marina UrenaLars Søndergaard
Sep 3, 2019·European Journal of Heart Failure·Bernard IungUNKNOWN MITRA-FR Investigators
Sep 14, 2018·Circulation Journal : Official Journal of the Japanese Circulation Society·Roberta De RosaGennaro Galasso
Sep 26, 2020·Korean Circulation Journal·Khung Keong Yeo, Ningyan Wong
Sep 14, 2018·Circulation Journal : Official Journal of the Japanese Circulation Society·Ching-Wei LeeKuo-Piao Chung
Oct 29, 2020·Arquivos brasileiros de cardiologia·Flavio TarasoutchiJosé Francisco Kerr Saraiva
Mar 16, 2021·Frontiers in Cardiovascular Medicine·Evgenia NikolouJulia Grapsa
May 4, 2020·The Journal of Thoracic and Cardiovascular Surgery·Heidi B Nafday, Eugene A Grossi
Sep 2, 2020·The Journal of Thoracic and Cardiovascular Surgery·Jean-Francois ObadiaDavid Messika-Zeitoun

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