Actively Recruiting

Age: 18Years +
All Genders
NCT02925819

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

Led by French Cardiology Society · Updated on 2025-02-13

500

Participants Needed

3

Research Sites

530 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged over 18 years
  • Severe mitral valve stenosis or regurgitation from any cause
  • Symptomatic with NYHA class II-IV despite optimized medical therapy
  • Judged not eligible for surgical treatment by a specialized multidisciplinary heart team
  • Informed about the study and not opposed to use of their data
  • Not currently included in a clinical trial
Not Eligible

You will not qualify if you...

  • Asymptomatic patients
  • No severe mitral regurgitation or stenosis
  • Eligible for surgical treatment by the heart team
  • Pregnant or breastfeeding women
  • Not informed about the study or opposed to data use

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

CHU Lyon

Lyon, France

Actively Recruiting

2

CHU Nantes

Nantes, France

Actively Recruiting

3

Bichat Hospital

Paris, France

Actively Recruiting

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Research Team

J

Jean-François OBADIA

CONTACT

B

Bernard IUNG

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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