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

NCT ID: NCT05836480

Last Updated: 2023-05-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 141 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-05
• Study Completion Date: 2019-10-15

Brief 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

Conditions

Mitral Regurgitation

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Suboptimal repair

Patients discharged with a residual mitral regurgitation of at least moderate (2+)degree

mitral valve repair

Intervention Type: PROCEDURE

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

Optimal repair

Patients discharged with a residual mitral regurgitation of mild (1+) or less degree (trace or 0)

mitral valve repair

Intervention Type: PROCEDURE

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

Interventions

mitral valve repair

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michele De Bonis

OTHER

Sponsor Role: lead

Responsible Party

Michele De Bonis

Chief of Cardiac Surgery of Advance and Research Therapies

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

IRCCS Ospedale San Raffaele

Milan, , Italy

Countries

Italy

Other Identifiers

SUB-MVR

Identifier Type: -

Identifier Source: org_study_id