MedicalResearch.com: What is the background for this study?
-By definition a secondary MR concerns a normal valve or sub normal valve inside a dilated heart with poor LV function in a population of Heart failure patients. It is perfectly established today that secondary MR is a predictor of poor clinical outcomes of thissevere population.
-Therefore,it has been proposed to treat those regurgitation either by surgery (mainly the downsizing anuloplasty) or by percutaneous technique like the mitraclipwhich has been used more and more frequently recently.
-However, a beneficial effect on hardclinical outcomes has never been provedandwe still don’t know if those regurgitations need to be corrected or not, We still don’t Know if the regurgitation is the cause, the consequence or just a marker of poor prognosis.
-In this context according to the guidelines, there is a low level of evidence to support those treatments, and Europe and US Guidelines call for prospective randomized studies in this severe population.
And this excatly what we have done with MITRA-FR