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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03113552
Other study ID # PI2013_843_0002
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 4, 2013
Est. completion date July 4, 2028

Study information

Verified date February 2023
Source Centre Hospitalier Universitaire, Amiens
Contact Catherine SZYMANSKI, Dr
Phone +33322455885
Email szymanski.catherine@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Mitral insufficiency (MI) accounts for 24% of adult valvulopathies and affects 7% of subjects older than 75 years. They are the second leading cause of valvulopathy in Europe. The most common etiology is the associated valvular prolapse. Mitral surgery remains the reference treatment for symptomatic MI. The success of this procedure depends on the mitral valve geometry and the location of the prolapse. The site of the prolapse, whether monovalvular, localized to the posterior or anterior leaflet, or bivalvular, influences the possibilities and probably the long-term results of the plasty.


Recruitment information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date July 4, 2028
Est. primary completion date July 4, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients operated between 1988 and 2011 - Presence of a valvular prolapse diagnosed by echocardiography - Possibility of a complete clinical evaluation at the time of the initial echocardiography Exclusion Criteria: - Ischemic MI (including papillary muscle rupture) - Presence of significant aortic valvulopathy, mitral valvular stenosis or congenital disease - History of cardiac surgery

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHU Amiens Picardie Amiens Picardie

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival defines as the time between the date of surgery and the death or date of the last news 6 months
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