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

Sponsor
Michele De Bonis (Other)
Overall Status
Completed
CT.gov ID
NCT05836480
Collaborator
(none)
141
1
10
429.2

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: mitral valve repair

Study Design

Study Type:
Observational
Actual Enrollment :
141 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study
Actual Study Start Date :
Oct 5, 2019
Actual Primary Completion Date :
Oct 15, 2019
Actual Study Completion Date :
Oct 15, 2019

Arms and Interventions

Arm Intervention/Treatment
Suboptimal repair

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

Procedure: mitral valve repair
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)

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

Outcome Measures

Primary Outcome Measures

  1. Mortality [through study completion, a minimum of 6 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

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 Advance and Research Therapies, Ospedale San Raffaele
ClinicalTrials.gov Identifier:
NCT05836480
Other Study ID Numbers:
  • SUB-MVR
First Posted:
May 1, 2023
Last Update Posted:
May 1, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 1, 2023