Management and Clinical Outcomes of Patients With Severe Mitral Valve Disease Not Suitable for Surgery
Management and Clinical Outcomes of Patients With Severe Mitral Valve Disease Not Suitable for Surgery
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.
Patients with symptomatic severe mitral valve disease will have a medical evaluation visit
 (physical examination, ECG, biology) with transthoracic ± transesophageal echocardiography in
 each center. If the patient is considered not eligible for surgery by the heart-team and is
 not included in a clinical trial, the investigator informs the patient of the existence of
 the registry and verifies that it does not express opposition to the use of its clinical
 data.

 In each participating center, demographic information, clinical, laboratory,
 echocardiographic and treatment options will be collected and reported in an electronic case
 report form (e-CRF). Each center will be responsible of patient monitoring, including phone
 call at 6 months and a medical visit at 1 and 2 years. Transthoracic echocardiography will
 also be performed at 1 year and 2 years.
-  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.

 -  Having received information about the study and not expressing opposition to the use
 of their data

 -  Patient not included in a clinical trial

 Exclusion Criteria:

 -  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

 -  Having not received information about the study or having expressed opposition to the
 use of their data