Skip to main content
OpenTrials
Completed

NCT Number: NCT05836480

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mitral Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mitral valve repair

Procedure

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

Primary outcomes

  1. Mortality

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

Sponsors and collaborators

Lead sponsor

Michele De Bonis

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 1, 2023
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.