Long Term Results in Redo Mitral Valve Surgery After Mitral Valve Repair

April 28, 2023 updated by: Michele De Bonis

The current gold standard for severe mitral regurgitation is mitral valve plasty (PLM). The surgery allows the repair of the mitral valve, therefore without the need for mitral valve replacement (SVM), which involves the implantation of a biological prosthesis or a mechanical prosthesis.

However, PLM has a rate of failure, between 1-4% per year in degenerative mitral pathologies. As a result, patients with PLM failure and severe residual regurgitation are increasingly presenting in recent years.

Generally these patients are re-operated to replace the mitral valve. Our aim is to investigate the differences in re-operation involving mitral valve replacement or re-repair in patients who underwent mitral valve re-operation (re-repair or replacement) in our center between 2003 and 2017.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

108

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 - Cardiac Surgery Department

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 with a failure of mitral valve repair. The patients are divided in 2 groups depending on type of reintervention: a new mitral valve repair (PLM) or mitral valve replacement (SVM)

Description

Inclusion Criteria:

  • adult patients
  • failure of previous mitral valve repair which needed a new surgical treatment
  • group Re-PLM: patients reoperated with a new mitral valve repair
  • group Re-SVM: patients reoperated with a mitral valve replacement

Exclusion Criteria:

  • urgent/emergent procedures

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
Re-PLM
Patient in which a new mitral valve repair is performed to treat failed mitral valve repair
Procedure: Mitral valve repair (PLM)
A mitral valve plasty is performed to treat mitral regurgitation
Re-SVM
Patient in which a mitral valve replacement is performed to treat failed mitral valve repair
Procedure: Mitral valve replacement
A mitral valve replacement with a prosthesis is performed to treat mitral regurgitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival after reintervention
Time Frame: through study completion, a minimum of 2 years
Time of survival after reintervention for failed mitral valve repair
through study completion, a minimum of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factors for reintervention
Time Frame: through study completion, a minimum of 2 years
Identification of predictors of reintervention after mitral valve repair
through study completion, a minimum of 2 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 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • LORESAR

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.

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