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

NCT05774769 | Completed

• 1 other identifier: COSMIR
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Mitral Valve Disease

Outcome Measures

Primary Outcomes (1)

• Mortality

  Through study completion, an average of 14,5 years

Interventions

Commissural edge to edge mitral valve repair PROCEDURE

Edge to edge is the suture of mitral valve leaflets tissue in the regurgitant spot. If the regurgitant jet is near a mitral commissure, it is called a commissural edge to edge.

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 with a degenerative mitral valve disease in whom regurgitation occurred in commissural position, hence were treated with a commisural edge to edge surgery

You may qualify if:

• 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.

You may not qualify if:

• Patients underwent a mitral valve replacement

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: March 20, 2023
• Study Start: October 9, 2021
• Primary Completion: October 19, 2021
• Study Completion: October 19, 2021
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)