title: 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.
abstract: OBJECTIVE
  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.
  
  
  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.
authors: Service de Chirurgie Cardiothoracique et Transplantation, Hôpital Cardiothoracique Louis Pradel, Lyon-Bron, France.
authors: Jean-François
authors: JF
authors: Obadia
authors: Xavier
authors: X
authors: Armoiry
authors: Bernard
authors: B
authors: Iung
authors: Thierry
authors: T
authors: Lefèvre
authors: Nathan
authors: N
authors: Mewton
authors: David
authors: D
authors: Messika-Zeitoun
authors: Bertrand
authors: B
authors: Cormier
authors: Julien
authors: J
authors: Berthiller
authors: Delphine
authors: D
authors: Maucort-Boulch
authors: Florent
authors: F
authors: Boutitie
authors: Bernadette
authors: B
authors: Vaz
authors: Jean-Noël
authors: JN
authors: Trochu
authors: Alec
authors: A
authors: Vahanian
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006328:Cardiac Catheterization / Q000379:methods*; D002311:Cardiomyopathy, Dilated / Q000150:complications / Q000628:therapy*; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D019468:Disease Management; D005260:Female; D006801:Humans; D008297:Male; D058386:Mitral Valve Annuloplasty / Q000379:methods*; D008944:Mitral Valve Insufficiency / Q000209:etiology / Q000628:therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents