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Management and Clinical Outcomes of Patients With Severe Mitral Valve Disease Not Suitable for Surgery

RECRUITINGSponsored by French Cardiology Society
Actively Recruiting
SponsorFrench Cardiology Society
Started2016-10
Est. completion2026-12
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
* 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

Conditions2

Heart DiseaseMitral Valve Disease

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