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

NCT05724537 | Completed

• 1 other identifier: DURQUAP 2017
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mitral Valve Disease

Outcome Measures

Primary Outcomes (1)

• Mortality

  Up to 20 years

Interventions

Quadrangular resection and annular plication PROCEDURE

Mitral regurgitation is treated removing the redundant tissue of the posterior leaflet, which is then reconstructed by sutures and plicating the posterior annulus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by degenerative MR, due to prolapse/flail of the posterior leaflet, treated with quadrangular resection of the posterior leaflet and annular plication

You may qualify if:

• 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

You may not qualify if:

• Other patients

Sponsors & Collaborators

• Michele De Bonis: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Cardiac Surgery of Advanced and Research Therapies

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 13, 2023
• Study Start: February 23, 2019
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)