French National Observatory of Percutaneous Mitral Commissurotomy

Completed

• Conditions: Mitral Stenosis

• Registration Number: NCT02783248
• Lead Sponsor: French Cardiology Society

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-05-19
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-05-26
• Study Start: 2016-06
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-20
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event free survival at 3 years	3 years	Measurement of event-free survival after good result of the PMC, observed in our study. The composite endpoint event-free survival is defined as: cardiovascular survival without reoperation on the mitral valve and patient in NYHA I-II at last follow

Trial Locations

Locations (1)

Bichat Hospital; 🇫🇷 Paris, France