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OpenTrials
Completed

NCT Number: NCT05724537

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Mortality

    Time frame: Up to 20 years

Sponsors and collaborators

Lead sponsor

Michele De Bonis

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 13, 2023
Registry last updated
Feb 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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