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

Degenerative Mitral Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05839782
• Other study ID #: LORESAR
• Status: Completed
• Start date: October 5, 2019
• Est. completion date: October 15, 2019

Study information

• Verified date: April 2023
• Source: Ospedale San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: October 15, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Mitral Valve Disease

Intervention

Procedure:
• Mitral valve repair (PLM)
A mitral valve plasty is performed to treat mitral regurgitation
• Mitral valve replacement
A mitral valve replacement with a prosthesis is performed to treat mitral regurgitation

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele - Cardiac Surgery Department	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Michele De Bonis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival after reintervention	Time of survival after reintervention for failed mitral valve repair	through study completion, a minimum of 2 years
Secondary	Risk factors for reintervention	Identification of predictors of reintervention after mitral valve repair	through study completion, a minimum of 2 years