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

Degenerative Mitral Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05774769
• Other study ID #: COSMIR
• Status: Completed
• Start date: October 9, 2021
• Est. completion date: October 19, 2021

Study information

• Verified date: March 2023
• Source: Ospedale San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: October 19, 2021
• Est. primary completion date: October 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Mitral Valve Disease
• Mitral Valve Insufficiency

Intervention

Procedure:
• Commissural edge to edge mitral valve repair
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.

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Michele De Bonis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		Through study completion, an average of 14,5 years