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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05839782
Enrollment
108
Registered
2023-05-03
Start date
2019-10-05
Completion date
2019-10-15
Last updated
2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Mitral Valve Disease

Brief summary

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.

Interventions

PROCEDUREMitral valve repair (PLM)

A mitral valve plasty is performed to treat mitral regurgitation

PROCEDUREMitral valve replacement

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

Sponsors

Michele De Bonis
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Survival after reinterventionthrough study completion, a minimum of 2 yearsTime of survival after reintervention for failed mitral valve repair

Secondary

MeasureTime frameDescription
Risk factors for reinterventionthrough study completion, a minimum of 2 yearsIdentification of predictors of reintervention after mitral valve repair

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026