About this trial
The objective of this study is to collect in a prospective registry all cases of French patients undergoing an assessment for percutaneous treatment of mitral valve disease on a native valve or due to deterioration after surgical valve repair or replacement. In these patients, valvular surgery should be considered contra-indicated or at prohibitive risk. This registry will evaluate the morbidity and mortality up to 24 months for those patients with severe mitral valve disease who are not included in a clinical trial. The association of demographic, clinical, laboratory, echocardiographic variables and treatment options with morbidity and mortality will be evaluated by univariate and multivariate analyses.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged over 18 years
Presenting with severe mitral valve stenosis or regurgitation regardless of etiology (primary mitral regurgitation, secondary mitral regurgitation, deterioration of mitral valve repair or bioprosthesis, mitral annular calcification)
Symptomatic (NYHA functional class II-IV) despite optimized medical therapy
Judged not eligible for surgical treatment according to a specialized multidisciplinary meeting called "heart team" comprising at least one cardiothoracic surgeon, one interventional cardiologist, one echocardiographer, one clinical cardiologist and one anaesthesiologist.
Disqualifiers
Asymptomatic patients
Absence of severe mitral regurgitation or stenosis
Patient judged eligible for surgical treatment according to a specialized multidisciplinary meeting called "heart team" comprising at least one cardiothoracic surgeon, one interventional cardiologist, one echocardiographer, one clinical cardiologist and one anaesthesiologist.
Pregnant or breastfeeding women
Trial population
French patients undergoing an assessment for percutaneous treatment of symptomatic severe mitral valve disease on a native valve or due to deterioration after surgical valve repair or replacement with contra-indication to or prohibitive risk of surgery.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
All cause death and heart failure at 24 months
Death from any cause or unscheduled hospitalization for heart failure at 24 months
Secondary outcomes
Overall survival at 24 months
The survival rate will be determined between the date of inclusion in the cohort and the date of occurrence of death, whatever the cause.
Survival without major cardiovascular event
The rate of survival without major cardiovascular event rate will be determined between the date of inclusion and date of occurrence of a major cardiovascular event (unscheduled rehospitalisation for heart failure, stroke, death of cardiovascular, myocardial infarction).
Rate of unscheduled hospitalizations for heart failure
Rate of unscheduled hospitalizations for heart failure at 24 months.
Functional evaluation
It will be defined by changes in NYHA functional class at 24 months.
Sponsors and contacts
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