- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05724537
Durability at 20 Years of Quadrangular Resection With Annular Plication for Mitral Regurgitation
February 9, 2023 updated by: Michele De Bonis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
145
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Milan, Italy, 20132
- IRCCS Ospedale San Raffaele
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality
Time Frame: Up to 20 years
|
Up to 20 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 23, 2019
Primary Completion (ACTUAL)
March 15, 2019
Study Completion (ACTUAL)
March 15, 2019
Study Registration Dates
First Submitted
January 30, 2023
First Submitted That Met QC Criteria
February 9, 2023
First Posted (ACTUAL)
February 13, 2023
Study Record Updates
Last Update Posted (ACTUAL)
February 13, 2023
Last Update Submitted That Met QC Criteria
February 9, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DURQUAP 2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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