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

April 28, 2023 updated by: Michele De Bonis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

141

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20132
        • IRCCS Ospedale San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent surgical mitral valve repair. Patients of study (Suboptimal) group were discharged with a 2+ or more residual mitral regurgitation, patients in control group (Optimal) were discharged with a 1+ or less residual mitral regurgitation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michele De Bonis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2019

Primary Completion (Actual)

October 15, 2019

Study Completion (Actual)

October 15, 2019

Study Registration Dates

First Submitted

January 27, 2023

First Submitted That Met QC Criteria

April 28, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUB-MVR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mitral Regurgitation

Clinical Trials on mitral valve repair

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe