Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study

Mitral Regurgitation Clinical Trial

Official title:

Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05836480
• Other study ID #: SUB-MVR
• Status: Completed
• Start date: October 5, 2019
• Est. completion date: October 15, 2019

Study information

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

Clinical Trial Summary

Mitral valve regurgitation is a pathology affecting the left atrioventricular valve, conditioning the loss of the normal unidirectionality of the atrioventricular flow and therefore volumetric and pressure overload of the left heart chambers. In industrialized countries, the most common etiology of mitral regurgitation is degenerative mitral disease.

Mitral valve repair surgery represents the gold standard for the treatment of severe degenerative mitral regurgitation. The expected optimal result would be the absence of residual post-procedural mitral regurgitation, even if it is not uncommon to obtain a valve with residual regurgitation of a mild degree. In some cases, for various reasons (technical difficulties, long aortic clamping time, advanced age, high pre-operative surgical risk), a suboptimal result is accepted, i.e. a post-procedural residual mitral regurgitation of even a moderate degree ( 0, 1+, or 2+/4+).

The aim of the present study is to evaluate the late clinical and echocardiographic implications of suboptimal mitral valve repair with a paired-data cohort study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: October 15, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Study group:

• presence of severe degenerative mitral regurgitation treated by mitral valve repair between 2006 and 2013;

• presence of moderate residual mitral regurgitation at discharge.

• Control group:

• presence of severe degenerative mitral regurgitation treated by mitral valve repair between 2006 and 2013;

• presence of residual mitral regurgitation of at least mild grade at discharge.

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Procedure:
• mitral valve repair
conservative surgery to treat mitral regurgitation. A mitral valve plasty is performed according to the most appropriate technique

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, a minimum of 6 years