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

NCT ID: NCT05839782

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-05

Study Completion Date

2019-10-15

Brief Summary

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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.

Detailed Description

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Conditions

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Degenerative Mitral Valve Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Re-PLM

Patient in which a new mitral valve repair is performed to treat failed mitral valve repair

Mitral valve repair (PLM)

Intervention Type PROCEDURE

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

Mitral valve replacement

Intervention Type PROCEDURE

A mitral valve replacement with a prosthesis is performed to treat mitral regurgitation

Interventions

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Mitral valve repair (PLM)

A mitral valve plasty is performed to treat mitral regurgitation

Intervention Type PROCEDURE

Mitral valve replacement

A mitral valve replacement with a prosthesis is performed to treat mitral regurgitation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Michele De Bonis

OTHER

Sponsor Role lead

Responsible Party

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Michele De Bonis

Chief of Cardiac Surgery of Advanced and Research Therapies

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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IRCCS Ospedale San Raffaele - Cardiac Surgery Department

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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LORESAR

Identifier Type: -

Identifier Source: org_study_id

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