French National Observatory of Percutaneous Mitral Commissurotomy (CALCIMIT)

French Cardiology Society

Status: Completed

Conditions: Mitral Stenosis

Study type: Observational

Funder types: Other

Identifiers

NCT02783248

15542

Details and patient eligibility

About

The aim of this study is to validate prospectively the predictive score of late results about a diverse population recruited in France and to evaluate the contribution in predicting the outcome of the PMC scanner to study the mitral calcium score and the location of the calcifications.

Full description

This is a multicenter prospective observational study conducted in French medico-surgical sites.

The Percutaneous Mitral Commissurotomy (PMC) is the standard treatment for Mitral stenosis (MS) in patients with rheumatic favorable characteristics. In Western countries the MS reaches older patients with less favorable characteristics, including the presence of mitral calcifications. Calcifications are a factor of poor outcome of the PMC. The scanner appears as a useful examination for their study but is not carried out systematically. The prediction of late results of the PMC is particularly important in patients with non-ideal characteristics which form a particularly heterogeneous population. A score of late results of the PMC on the wider western series was recently released but has not to date received external validation. In this score, prediction results was multifactorial, with a consideration of paramount clinical factors, but also a prognostic significance of mitral calcifications.

The validation of predictive score of late results of the PMC, with the analysis of calcifications, would better select patients who may best benefit from PMC and those for which the surgical management is preferred.

The aim of this study is to validate an external sample predictive score of the event-free survival in patients who have had a good immediate result of the PMC.

This study, purely observational, does not create any special procedure outside the patient's usual care.

Enrollment: 301 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• This will include all consecutive patients with rheumatic MS referred for PMC
• Patients who agreed to participate in the study, with signed consent

Exclusion criteria

• Contraindication to the PMC
• Contraindication to non injected scanner for centers performing a scanner
• Patient Refusal to participate in the study

Trial design

301 participants in 1 patient group

Mitral Stenosis

Description:

No specific protocol intervention occurs. All the cares are made as done usually. Patients who may be included are all consecutive patients who agreed to participate in the study and having a PMC in a French medical-surgical centers that perform more than 5 year PMC. All patients undergoing echocardiography with the realization of the score Wilkins and Cormier. Will then be included to validate the result of late score that patients who had a good immediate result of the PMC defined by: mitral valve area ≥ 1.5 cm² and IM ≤ 2/4. Patients with a poor immediate result of the PMC will not be monitored as part of the study but their data will be collected for the description of the population and analysis of immediate results. Patients in the study will receive an annual monitoring as recommended, independently of the study.