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Completed

NCT Number: NCT02783248

French National Observatory of Percutaneous Mitral Commissurotomy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bichat Hospital

Paris, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Event free survival at 3 years

    Time frame: 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

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Registry information

Official study title

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

Acronym: CALCIMIT

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
May 26, 2016
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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