Study of Innovative Strategies for Mitral Valve Repair

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Congenital Mitral Insufficiency

Intervention / Treatment
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* Procedure: 3-steps standardized repair-oriented strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: < 14 years old had not undertake mitral valve surgery before moderate to severe mitral regurgitation Exclusion Criteria: moderate to severe mitral regurgitation which concommitant with other cardiac malformation which can not be correct or can only perform palliative surgery concommitant with mitral stenosis ischemic mitral regurgitation (for example, concommitant with anomalous origin of coronary artery) Barlow syndrome dysplasia of mitral leaflet complete/Partial endocardial cushion defect common atrioventricular valve atrioventricular common channel cardiomyopathy other mitral valve surgery contraindications

Ages Eligible for Study
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Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standardized Group<br>Patients in this group will undergo standardized strategy during mitral repair surgeries, including subvalvular apparatus rehabilitation, leaflets repair and annuloplasty. | Procedure: 3-steps standardized repair-oriented strategy<br>* 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.)<br>|
| Annuloplasty Group<br>Patients in this group will undergo annuloplasty only during mitral repair surgeries. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the recurrence rate of moderate to severe mitral valve regurgitation | During follow-up visits, echocardiographic examination is conducted to measure the degree of mitral valve regurgitation. If it falls within the moderate to severe range, it is recorded as a recurrence. | after 6 months of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in symptoms | Based on patient and caregiver descriptions, if symptoms such as chest discomfort, shortness of breath, and delayed development show improvement following physical activity, it is recorded as an improvement in symptoms. | after 6 months of surgery | 
| Change in left ventricular function | Based on the echocardiogram, measurements are taken for left ventricular ejection fraction. | after 6 months of surgery | 
| Change in left ventricular function | Based on the echocardiogram, measurements are taken for left ventricular end-diastolic diameter. | after 6 months of surgery | 
| NT-proBNP level | The trend in NT-proBNP levels. | after 6 months of surgery | 
| Incidence rate of surgical complications | Incidence rate of surgical complications, including infection, low cardiac output, arrhythmia, cardiac insufficiency, delayed sternal closure, thromboembolism and bleeding events, neurological complications(stroke, seizures and intracerebral hemorrhage). | after 6 months of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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congenital heart disease, mitral regurgitation, mitral valve repair