Skip to content

French National Observatory of Percutaneous Mitral Commissurotomy

French National Observatory of Percutaneous Mitral Commissurotomy (PMC) Immediate Score, Scanner, Late Results

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02783248
Acronym
CALCIMIT
Enrollment
301
Registered
2016-05-26
Start date
2016-06-30
Completion date
2022-06-30
Last updated
2022-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Stenosis

Keywords

Percutaneous mitral commissurotomy, Mitral Stenosis

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.

Interventions

None listed

Sponsors

French Cardiology Society
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Event free survival at 3 years3 yearsMeasurement 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026