Prognostic Impact of the Location of Mitral Valve Prolapse on the Long-term Results of Mitral Plasty

Mitral Valve Prolapse Clinical Trial

— IPPVM  

Official title:

Prognostic Impact of the Location of Mitral Valve Prolapse on the Long-term Results of Mitral Plasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03113552
• Other study ID #: PI2013_843_0002
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Mitral Plasty
• Mitral Valve Prolapse
• Prolapse

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