Informations générales (source: ClinicalTrials.gov)
Management And Clinical Outcomes Of Patients With Severe Mitral Disease Not Suitable For Surgery: A Prospective, Multicentric, Observational Study (MITRAGISTER)
Observational [Patient Registry]
French Cardiology Society (Voir sur ClinicalTrials)
octobre 2016
décembre 2026
05 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bichat | Bernard Iung | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Lyon - Lyon - France | Jean-Francois Obadia | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Nantes - Nantes - France | Patrice Guérin | Contact (sur clinicalTrials) | |||
Critères
Tous
- 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
- 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