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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- the recurrence rate of moderate to severe mitral valve regurgitation
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •< 14 years old
- •had not undertake mitral valve surgery before
- •moderate to severe mitral regurgitation
排除标准
- •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
结局指标
主要结局
the recurrence rate of moderate to severe mitral valve regurgitation
时间窗: after 6 months of surgery
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.
次要结局
- NT-proBNP level(after 6 months of surgery)
- Improvement in symptoms(after 6 months of surgery)
- Change in left ventricular function(after 6 months of surgery)
- Incidence rate of surgical complications(after 6 months of surgery)
研究者
Shoujun Li
Director of Congenital Heart Surgery Center
China National Center for Cardiovascular Diseases