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Clinical Trials/NCT05836480
NCT05836480
Completed
N/A

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

Michele De Bonis1 site in 1 country141 target enrollmentOctober 5, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mitral Regurgitation
Sponsor
Michele De Bonis
Enrollment
141
Locations
1
Primary Endpoint
Mortality
Status
Completed
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
October 5, 2019
End Date
October 15, 2019
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 Advance and Research Therapies

Ospedale San Raffaele

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

  • Not provided

Outcomes

Primary Outcomes

Mortality

Time Frame: through study completion, a minimum of 6 years

Study Sites (1)

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