Commissural Closure to Treat Severe Mitral Regurgitation: Standing the Test of Time.

Completed

• Conditions: Degenerative Mitral Valve Disease

• Registration Number: NCT05774769
• Lead Sponsor: Michele De Bonis

Brief Summary

Mitral regurgitation (MR) for degenerative disease is nowadays routinely treated with valve repair with excellent short and long term results in experienced centers. However, repair durability can varies according to the characteristics of the initial lesion, and better long term durability in isolated lesions of the posterior leaflets compared to anterior or bi-leaflets prolapse has been shown. A commissural MR can be caused by lesions of the anterior, posterior or both leaflets and several surgical techniques have been proposed to treat these lesions. However, long term outcomes of mitral valve repair (MVr) for isolated commissural flail or prolapse remain poor defined. In San Raffaele Hospital cardiac surgery, commissural lesions are usually treated with a functional approach, by means of edge-to-edge approximation of the anterior and posterior leaflet at the commissural area (commissural closure). The investigators previously reported the short and mid-term outcomes of this technique with satisfactory results. With this study the investigators aim to analyze the very long term clinical and echocardiographic results of isolated commissural lesions treated with commissural closure.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-09
• Primary Completion: 2021-10-19
• Study Completion: 2021-10-19
• Study First Submitted: 2023-01-30
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-16
• Last Update Submitted: 2023-03-16
• Study First Posted: 2023-03-20
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• Adult patients;
• Patients underwent mitral valve repair for flail or isolated commissural prolapse, of posterior, anterior or bileaflet origin;
• Patients operated on with median sternotomy or left minithoracotomy;
• Patients in whom the commissural MR has been treated with commissural closure and annuloplasty;
• Patients operated on at the Cardiac Surgery department of San Raffaele Hospital from January 1997 to December 2007.

Exclusion Criteria

• Patients underwent a mitral valve replacement

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	Through study completion, an average of 14,5 years

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Italy