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Clinical Trials/NCT05774769
NCT05774769
Completed
Not Applicable

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

Michele De Bonis1 site in 1 country125 target enrollmentOctober 9, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Degenerative Mitral Valve Disease
Sponsor
Michele De Bonis
Enrollment
125
Locations
1
Primary Endpoint
Mortality
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 9, 2021
End Date
October 19, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Michele De Bonis

Chief of Cardiac Surgery of Advanced and Research Therapies

Ospedale San Raffaele

Eligibility Criteria

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

Outcomes

Primary Outcomes

Mortality

Time Frame: Through study completion, an average of 14,5 years

Study Sites (1)

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