Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
256 participants
OBSERVATIONAL
2022-04-01
2024-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Standardized Group
Patients in this group will undergo standardized strategy during mitral repair surgeries, including subvalvular apparatus rehabilitation, leaflets repair and annuloplasty.
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.)
Annuloplasty Group
Patients in this group will undergo annuloplasty only during mitral repair surgeries.
No interventions assigned to this group
Interventions
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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.)
Eligibility Criteria
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Inclusion Criteria
* had not undertake mitral valve surgery before
* moderate to severe mitral regurgitation
Exclusion Criteria
* 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
14 Years
ALL
No
Sponsors
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Shanghai Children's Medical Center
OTHER
Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
Guangzhou Women and Children's Medical Center
OTHER
Children's Hospital of Chongqing Medical University
OTHER
China National Center for Cardiovascular Diseases
OTHER_GOV
Responsible Party
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Shoujun Li
Director of Congenital Heart Surgery Center
Principal Investigators
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Shoujun Li, MD
Role: STUDY_CHAIR
Chinese Academy of Medical Sciences, Fuwai Hospital
Locations
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Fuwai hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-GSP-GG-19-2
Identifier Type: -
Identifier Source: org_study_id
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