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

• Sponsor: Michele De Bonis (Other)
• Overall Status: Completed
• CT.gov ID: NCT05724537
• Collaborator: (none)
• Enrollment: 145
• Location: 1
• Actual Duration (Days): 20
• Patients Per Site Per Month: 220.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mitral Valve Disease	Procedure: Quadrangular resection and annular plication

Study Design

• Study Type: Observational
• Actual Enrollment: 145 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Durability at 20 Years of Quadrangular Resection With Annular Plication for Mitral Regurgitation
• Actual Study Start Date: Feb 23, 2019
• Actual Primary Completion Date: Mar 15, 2019
• Actual Study Completion Date: Mar 15, 2019

Outcome Measures

Primary Outcome Measures

1. Mortality [Up to 20 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Ospedale San Raffaele	Milan		Italy	20132

Sponsors and Collaborators

• Michele De Bonis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michele De Bonis, Chief of Cardiac Surgery of Advanced and Research Therapies, Ospedale San Raffaele
• ClinicalTrials.gov Identifier: NCT05724537
• Other Study ID Numbers: DURQUAP 2017
• First Posted: Feb 13, 2023
• Last Update Posted: Feb 13, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Mitral Valve Insufficiency

Study Results

No Results Posted as of Feb 13, 2023