Management and Clinical Outcomes of Patients With Severe Mitral Valve Disease Not Suitable for Surgery (MITRAGISTER)

September 15, 2022 updated by: French Cardiology Society

Management And Clinical Outcomes Of Patients With Severe Mitral Disease Not Suitable For Surgery: A Prospective, Multicentric, Observational Study

The objective of this study is to collect in a prospective registry all cases of French patients undergoing an assessment for percutaneous treatment of mitral valve disease on a native valve or due to deterioration after surgical valve repair or replacement. In these patients, valvular surgery should be considered contra-indicated or at prohibitive risk. This registry will evaluate the morbidity and mortality up to 24 months for those patients with severe mitral valve disease who are not included in a clinical trial. The association of demographic, clinical, laboratory, echocardiographic variables and treatment options with morbidity and mortality will be evaluated by univariate and multivariate analyses.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Patients with symptomatic severe mitral valve disease will have a medical evaluation visit (physical examination, ECG, biology) with transthoracic ± transesophageal echocardiography in each center. If the patient is considered not eligible for surgery by the heart-team and is not included in a clinical trial, the investigator informs the patient of the existence of the registry and verifies that it does not express opposition to the use of its clinical data.

In each participating center, demographic information, clinical, laboratory, echocardiographic and treatment options will be collected and reported in an electronic case report form (e-CRF). Each center will be responsible of patient monitoring, including phone call at 6 months and a medical visit at 1 and 2 years. Transthoracic echocardiography will also be performed at 1 year and 2 years.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lyon, France
        • Recruiting
        • CHU LYON
        • Contact:
          • Jean-Francois Obadia
      • Nantes, France
        • Recruiting
        • CHU Nantes
        • Contact:
          • Patrice Guérin
      • Paris, France
        • Recruiting
        • Bichat Hospital
        • Contact:
          • Bernard Iung

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

French patients undergoing an assessment for percutaneous treatment of symptomatic severe mitral valve disease on a native valve or due to deterioration after surgical valve repair or replacement with contra-indication to or prohibitive risk of surgery.

Description

  • Aged over 18 years
  • Presenting with severe mitral valve stenosis or regurgitation regardless of etiology (primary mitral regurgitation, secondary mitral regurgitation, deterioration of mitral valve repair or bioprosthesis, mitral annular calcification)
  • Symptomatic (NYHA functional class II-IV) despite optimized medical therapy
  • Judged not eligible for surgical treatment according to a specialized multidisciplinary meeting called "heart team" comprising at least one cardiothoracic surgeon, one interventional cardiologist, one echocardiographer, one clinical cardiologist and one anaesthesiologist.
  • Having received information about the study and not expressing opposition to the use of their data
  • Patient not included in a clinical trial

Exclusion Criteria:

  • Asymptomatic patients
  • Absence of severe mitral regurgitation or stenosis
  • Patient judged eligible for surgical treatment according to a specialized multidisciplinary meeting called "heart team" comprising at least one cardiothoracic surgeon, one interventional cardiologist, one echocardiographer, one clinical cardiologist and one anaesthesiologist.
  • Pregnant or breastfeeding women
  • Having not received information about the study or having expressed opposition to the use of their data

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
SEVERE MITRAL VALVE DISEASE
All patients with symptomatic severe mitral valve disease on a native valve or due to deterioration after surgical valve repair or replacement, and not eligible for surgery according to the heart-team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause death and heart failure at 24 months
Time Frame: 24 months of follow-up
Death from any cause or unscheduled hospitalization for heart failure at 24 months
24 months of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival at 24 months
Time Frame: 24 months of follow-up
The survival rate will be determined between the date of inclusion in the cohort and the date of occurrence of death, whatever the cause.
24 months of follow-up
Survival without major cardiovascular event
Time Frame: 24 months of follow-up
The rate of survival without major cardiovascular event rate will be determined between the date of inclusion and date of occurrence of a major cardiovascular event (unscheduled rehospitalisation for heart failure, stroke, death of cardiovascular, myocardial infarction).
24 months of follow-up
Rate of unscheduled hospitalizations for heart failure
Time Frame: 24 months of follow-up
Rate of unscheduled hospitalizations for heart failure at 24 months.
24 months of follow-up
Functional evaluation
Time Frame: 24 months of follow-up
It will be defined by changes in NYHA functional class at 24 months.
24 months of follow-up
Early safety
Time Frame: Until Hospital Discharge, up to 6 months
Defined as absence of all-cause mortality, all stroke, severe bleeding, acute kidney injury stage 2 or 3, major vascular complication, and valve related dysfunction requiring repeat interventional transcatheter procedure or surgery.
Until Hospital Discharge, up to 6 months

Collaborators and Investigators

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

Sponsor

French Cardiology Society

Investigators

  • Principal Investigator: Jean-François OBADIA, CHU LYON
  • Principal Investigator: Patrice GUERIN, CHU Nantes

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)

October 1, 2016

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

June 1, 2026

Study Registration Dates

First Submitted

September 8, 2016

First Submitted That Met QC Criteria

October 5, 2016

First Posted (Estimate)

October 6, 2016

Study Record Updates

Last Update Posted (Actual)

September 16, 2022

Last Update Submitted That Met QC Criteria

September 15, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15.534

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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