Clinical trial NCT02783248: French National Observatory of Percutaneous Mitral Commissurotomy
Official title: French National Observatory of Percutaneous Mitral Commissurotomy (PMC) Immediate Score, Scanner, Late Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Stenosis
Keywords: Percutaneous mitral commissurotomy
Mitral Stenosis
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 PMC annually.

The estimated number of patients is 500 over a period of 3 years. The inclusion of patients in the study is performed in the center of the referent investigating physician liability

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.

Eligibility criteria: 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

Primary outcomes:
measure: Event free survival at 3 years
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Bichat Hospital
Study officials:
References:
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