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| Name | Class |
|---|---|
| Shanghai Children's Medical Center | OTHER |
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
| Guangzhou Women and Children's Medical Center | OTHER |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standardized Group | Patients in this group will undergo standardized strategy during mitral repair surgeries, including subvalvular apparatus rehabilitation, leaflets repair and annuloplasty. |
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| Annuloplasty Group | Patients in this group will undergo annuloplasty only during mitral repair surgeries. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3-steps standardized repair-oriented strategy | Procedure | 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.) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Children under the age of 14 with moderate to severe mitral valve regurgitation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kai Ma, PhD | Contact | +86 15901428497 | drmakaifw@yahoo.com | |
| Zheng Dou, PhD | Contact | +86 18810673618 | drdouzheng@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shoujun Li, MD | Chinese Academy of Medical Sciences, Fuwai Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai hospital | Recruiting | Beijing | Beijing Municipality | 100037 | China |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| Children's Hospital of Chongqing Medical University |
| OTHER |
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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 |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006349 | Heart Valve Diseases |