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NCT05724537 Clinical Trial

Durability at 20 Years of Quadrangular Resection With Annular Plication for Mitral Regurgitation

Mitral Valve Disease Clinical Trial

Official title:
Durability at 20 Years of Quadrangular Resection With Annular Plication for Mitral Regurgitation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05724537
Other study ID # DURQUAP 2017
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 23, 2019
Est. completion date March 15, 2019

Study information
Verified date February 2023
Source Ospedale San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Degenerative mitral regurgitation (MR) due to prolapse of the posterior leaflet is the most common dysfunction of the mitral valve (MV) in the Western world and is nowadays treated with a variety of surgical techniques. Quadrangular resection combined with annular plication and annuloplasty, as originally described by Carpentier, has been the standard approach for many years, before sliding/folding plasty and artificial chordae gained larger popularity.However, very few studies have been published on thevery long-term results (up to 20 years) of quadrangular resection and annular plication, often reporting only freedom from reoperation rather than from recurrent MR. This study aims to evaluate the very long-term (20 years) clinical and echocardiographic results of this approach, which was used for many years at the beginning of our mitral repair program.

Recruitment information / eligibility
Status Completed
Enrollment 145
Est. completion date March 15, 2019
Est. primary completion date March 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients - Affected by mitral valve posterior leaflet prolapse/flail causing severe mitral regurgitation - Treated with quadrangular resection of the posterior leaflet and annulus plication Exclusion Criteria: - Other patients

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Quadrangular resection and annular plication
Mitral regurgitation is treated removing the redundant tissue of the posterior leaflet, which is then reconstructed by sutures and plicating the posterior annulus

Locations
Country Name City State
Italy IRCCS Ospedale San Raffaele Milan

Sponsors (1)
Lead Sponsor Collaborator
Michele De Bonis

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality Up to 20 years
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