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

NCT05839782 | Completed

• 1 other identifier: LORESAR
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Mitral Valve Disease

Outcome Measures

Primary Outcomes (1)

• Survival after reintervention

  Time of survival after reintervention for failed mitral valve repair

  through study completion, a minimum of 2 years

Secondary Outcomes (1)

• Risk factors for reintervention

  through study completion, a minimum of 2 years

Study Arms (2)

Re-PLM

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

Procedure: Mitral valve repair (PLM)

Re-SVM

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

Procedure: Mitral valve replacement

Interventions

Mitral valve repair (PLM) PROCEDURE

A mitral valve plasty is performed to treat mitral regurgitation

Re-PLM

Mitral valve replacement PROCEDURE

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

Re-SVM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• urgent/emergent procedures

Sponsors & Collaborators

• Michele De Bonis: lead

Study Sites (1)

IRCCS Ospedale San Raffaele - Cardiac Surgery Department

Milan, 20132, Italy

Location

MeSH Terms

Interventions

phospholemman

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Cardiac Surgery of Advanced and Research Therapies

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: May 3, 2023
• Study Start: October 5, 2019
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)