Clinical Trial

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

Study acronym: MITRAGISTER
Recruiting
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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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2016-10-05; most recent amendment 2026-06-11.
Status change: Not Yet Recruiting → Recruiting 2016-10-10
Trial Details
NCT Number NCT02925819
Lead Sponsor French Cardiology Society
Conditions Mitral Valve Disease
Enrollment 500 participants
Start Date 2016-10
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-12