Management and Clinical Outcomes of Patients With Severe Mitral Valve Disease Not Suitable for Surgery
Management And Clinical Outcomes Of Patients With Severe Mitral Disease Not Suitable For Surgery: A Prospective, Multicentric, Observational Study
French Cardiology Society
500 participants
Oct 1, 2016
OBSERVATIONAL
Conditions
Summary
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
Inclusion Criteria6
- 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 Criteria5
- 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
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Locations(3)
View Full Details on ClinicalTrials.gov
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NCT02925819