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Clinical Trials/NCT05839782
NCT05839782
Completed
N/A

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

Michele De Bonis1 site in 1 country108 target enrollmentOctober 5, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Degenerative Mitral Valve Disease
Sponsor
Michele De Bonis
Enrollment
108
Locations
1
Primary Endpoint
Survival after reintervention
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 5, 2019
End Date
October 15, 2019
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Michele De Bonis

Chief of Cardiac Surgery of Advanced and Research Therapies

Ospedale San Raffaele

Eligibility Criteria

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

Outcomes

Primary Outcomes

Survival after reintervention

Time Frame: through study completion, a minimum of 2 years

Time of survival after reintervention for failed mitral valve repair

Secondary Outcomes

  • Risk factors for reintervention(through study completion, a minimum of 2 years)

Study Sites (1)

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