NCT06037447

Study of Innovative Strategies for Mitral Valve Repair

A Prospective Controlled Study for the Treatment Effect of Different Intervention Strategies for Pediatric Mitral Regurgitation--A Multicenter Prospective Cohort Study of Innovative Strategies for Mitral Valve Repair

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 256 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to compare the safety and effectiveness of a 3-steps standardized repair-oriented strategy with annuloplasty only in pediatric patients with mild to moderate mitral valve regurgitation. The main questions it aims to answer are: * Can 3-steps standardized repair-oriented strategy improve both left ventricular and mitral valve function in pediatric patients with mild to moderate mitral valve regurgitation? * Can surgical complications caused by the 3-steps standardized repair-oriented strategy be non-inferior (clinically acceptable) to annuloplasty only? Participants will be assigned to either the Standardized Group (including subvalvular apparatus rehabilitation (leaflet plication if chordae absent on leaflet margin, mal-connected chordae resection if chordae mal-connected to leaflet body, papillary muscle splitting if short chordae or dysplastic or fused papillary muscle etc.), leaflets repair (leaflets plication if functional leaflet prolapse, leaflet cleft closure and patch augmentation for anatomical leaflet defect, etc.) and annuloplasty (posterior annuloplasty for annular dilatation and shallow leaflet coaptation, etc.)) or the Annuloplasty Group (annuloplasty only during mitral repair surgeries. Additionally, echocardiography, electrocardiograms, and measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) were conducted before the initiation of surgery and at 1 months, 3 months, and 6 months after mitral repair. Researchers will compare the Standardized Group and the Annuloplasty Group to see if the recurrence rate of moderate to severe mitral valve regurgitation, as assessed by echocardiography after 6 months of surgery, is lower in the former than in the latter.

Conditions

• Congenital Mitral Insufficiency

Interventions

Type	Name	Description
PROCEDURE	3-steps standardized repair-oriented strategy	3-steps standardized repair-oriented strategy, including subvalvular apparatus rehabilitation (leaflet plication if chordae absent on leaflet margin, mal-connected chordae resection if chordae mal-connected to leaflet body, papillary muscle splitting if short chordae or dysplastic or fused papillary muscle etc.), leaflets repair (leaflets plication if functional leaflet prolapse, leaflet cleft closure and patch augmentation for anatomical leaflet defect, etc.) and annuloplasty (posterior annuloplasty for annular dilatation and shallow leaflet coaptation, etc.)

Timeline

• Start date: 2022-04-01
• Primary completion: 2024-04-05
• Completion: 2024-12-31
• First posted: 2023-09-14
• Last updated: 2023-09-15

Locations

1 site across 1 country: China