March 1, 2015
View Full PaperThe 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
Key Result
The MITRA-FR study is a randomized controlled trial designed to enroll 288 patients to evaluate percutaneous mitral valve repair using MitraClip plus OMT versus OMT alone for severe secondary MR.
Study Design
Type
RCT (n=288)
Blinding
Open-label
Randomization
Randomized
Multicenter
Yes
Structured PICO
Does percutaneous mitral valve repair using the MitraClip system plus optimal medical therapy reduce the composite of all-cause mortality and unplanned hospitalisations for heart failure in patients with severe symptomatic secondary mitral regurgitation contraindicated to surgical repair compared to optimal medical therapy alone?
P
Population
288 (target) patients with severe symptomatic secondary mitral regurgitation (MR) contraindicated to surgical repair
I
Intervention
Percutaneous mitral valve repair (pMVR) using the MitraClip system plus optimal medical therapy (OMT)
C
Comparator
Optimal medical therapy (OMT) alone
O
Outcome
Composite of all-cause mortality and unplanned hospitalisations for heart failure at 12 months after randomisationcomposite
The MITRA-FR study is designed to evaluate the efficacy and safety of percutaneous mitral valve repair using the MitraClip system in patients with severe secondary mitral regurgitation contraindicated to surgery.
Abstract
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.