French National Observatory of Percutaneous Mitral Commissurotomy (CALCIMIT)

September 20, 2022 updated by: French Cardiology Society

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

301

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Bichat Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Mitral Stenosis

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Cardiology Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

May 19, 2016

First Submitted That Met QC Criteria

May 25, 2016

First Posted (Estimate)

May 26, 2016

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 20, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15542

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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