German Clinical Trials Register

Acronym/abbreviation of the study

EURO-SMR

URL of the study

http://na

Brief summary in lay language

This international retrospective European registry is including patients with so-called secondary mitral regurgitation who underwent transcatheter mitral valve repair. Aim of this registry is to characterize in depth the this mitral valve disease and underlying heart disease. Secondary mitral regurgitation (MR) is defined, in contrast to primary MR, as being caused by a relevant heart disease. This could be e.g. an impaired left ventricular pump function due to chronic ischemic heart disease or long-standing atrial fibrillation with dilatation of the valve apparatus. For several years now, patients with severe secondary MR, can be treated with transcatheter mitral valve repair methods. The success of the transcatheter mitral valve repair will bei assessed in this registry as well, which is defined as a reduction of MR severity. The reduction of MR leads to the therapeutic effect with potentially improved symptoms and probably prognosis, in particular a reduction of hospitalizations and maybe longer survival. For the treatment of secondary mitral regurgitation, many scientific questions are not answered yet, in particular which patients benefit in particularonly from the procedure in the long term. To answer these questions, the scientific focus is to investigate the influence of patient characteristics and valve and heart anatomy on longterm survival, symptom improvement and stability of reduction of mitral regurgitation. This information is provided from the respective center into a database in an anonymized manner. The scientific questions can be answered from this database. We expect that in sum between 1000 and 2000 patients from all centers will be included in this registry. The anonymized data will be centrally analyzed to answer the above mentioned scientific questions. The results will be published in scientific journals to provide this important information to health care professionals.

Brief summary in scientific language

It is well known that severe secondary mitral regurgitation (SMR) has a poor prognosis and substantial morbidity in patients with heart failure and reduced ejection fraction (HFrEF). Therefore, transcatheter mitral valve repair (TMVR) is a guideline-recommended therapy in symptomatic patients with SMR after optimal medical or device (cardiac resynchronization) therapy. Two recent randomized trials reported conflicting results regarding hospitalization for heart failure and mortality in patients undergoing TMVR for SMR (COAPT trial, MITRA-FR trial. A possible explanation could be different patient populations in both studies in terms of preprocedural quantitative MR severity and LV size. The results of both studies and others underline the importance of meticulous preprocedural patient selection for TMVR to achieve best possible results and long-lasting benefit. For patients undergoing surgical mitral valve repair (SMVR), studies identified predictors for MR recurrence and long-term mortality including detailed examination of MV geometry. Regarding TMVR, previous reports revealed impairment of LV-EF, reduced kidney function, right-ventricular dysfunction and advanced age as independent predictors for long-term mortality. Other studies pointed out the importance of preprocedural pulmonary hypertension and restricted posterior leaflet motion as independent predictors for MR recurrence. Nevertheless there has been no structured echocardiographic analysis in patients with SMR treated with TMVR in order to identify anatomic MV and left heart predictors for several relevant endpoints as acute procedural failure (APF), mid-term recurrence of MR and reintervention, and long-term mortality. Therefore, this study aims at identifying preprocedural echocardiographic and reevaluate clinical predictors for acute procedural failure, mid-term recurrence of mitral regurgitation and need for repeat intervention in addition to mortality in order to improve future patient selection for TMVR in a real-world Setting. In particular, Centers will put anonymous Information into the database: age, gender, procedure date, date of death, date of last follow-up, size, weight, Body mass index, surgical risk (with logEuroScore, Euroscore II), creatinine clearance, MR degree before, after and at follow-up, Symptoms (NYHA) before, after and at follow-up, echocardiographic data (regurgitation area, regurgitation volume, LV volume). diabetes, arterial hypertension, recent myocardial infarction, recent coronary intervention, recent aorto coronary bypass, , prior stroke, chronic lung disease, atrial fibrillation, presence of pacemaker or defibrillator. The association of these parameters with endpoints (Death, hospizalization, see prior Explanation) will be investigated by statistical means and the results published.