Comparing mitral valve repair strategies in children
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
China National Center for Cardiovascular Diseases · NCT06037447
This study is testing two different ways to fix a heart valve in children under 14 with mild to moderate valve problems to see which method works better and is safer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 256 (estimated) |
| Ages | N/A to 14 Years |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases (other gov) |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06037447 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and effectiveness of a three-step standardized repair-oriented strategy versus annuloplasty alone in pediatric patients with mild to moderate mitral valve regurgitation. The study will assess improvements in left ventricular and mitral valve function while monitoring for surgical complications. Participants will be assigned to one of the two treatment groups based on their eligibility criteria, which includes children under 14 years old who have not previously undergone mitral valve surgery.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients under 14 years old with moderate to severe mitral regurgitation who have not had prior mitral valve surgery.
Not a fit: Patients with other significant cardiac malformations or conditions that contraindicate mitral valve surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and heart function in children with mitral valve issues.
How similar studies have performed: While this approach is innovative, similar studies have shown varying degrees of success in improving surgical outcomes in pediatric cardiac patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing, Beijing
- Fuwai hospital — Beijing, Beijing, China (RECRUITING)
Study contacts
- Study coordinator: Kai Ma, PhD
- Email: drmakaifw@yahoo.com
- Phone: +86 15901428497
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Congenital Mitral Insufficiency, congenital heart disease, mitral regurgitation, mitral valve repair