Management and Clinical Outcomes of Patients With Severe Mitral Valve Disease Not Suitable for Surgery
Recruiting now
Conditions studied: Mitral Valve Disease
In brief
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.
Key facts
- Study ID
- NCT02925819
- Run by
- French Cardiology Society
- People needed
- 500
- Starts
- 2016-10-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-06-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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
Where it is running
- CHU Lyon — Lyon, France (enrolling)
- CHU Nantes — Nantes, France (enrolling)
- Bichat Hospital — Paris, France (enrolling)
Full record on ClinicalTrials.gov
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