NCT05774769

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 125 (actual)
• Sponsor: Michele De Bonis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-09
• Primary completion: 2021-10-19
• Completion: 2021-10-19
• First posted: 2023-03-20
• Last updated: 2023-03-20

Locations

1 site across 1 country: Italy