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

Sponsor

Michele De Bonis (Other)

Overall Status

Completed

CT.gov ID

NCT05774769

Collaborator

(none)

125

Enrollment

Location

Actual Duration (Days)

380.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Degenerative Mitral Valve Disease	Procedure: Commissural edge to edge mitral valve repair

Study Design

Study Type:

Observational

Actual Enrollment :

125 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Oct 9, 2021

Actual Primary Completion Date :

Oct 19, 2021

Actual Study Completion Date :

Oct 19, 2021

Outcome Measures

Primary Outcome Measures

Mortality [Through study completion, an average of 14,5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Ospedale San Raffaele	Milan		Italy	20132

Sponsors and Collaborators

Michele De Bonis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michele De Bonis, Chief of Cardiac Surgery of Advanced and Research Therapies, Ospedale San Raffaele

ClinicalTrials.gov Identifier:

NCT05774769

Other Study ID Numbers:

COSMIR

First Posted:

Mar 20, 2023

Last Update Posted:

Mar 20, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mitral Valve Insufficiency

Study Results

No Results Posted as of Mar 20, 2023