Comparing mitral valve repair strategies in children
Official title: 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
Run by China National Center for Cardiovascular Diseases · NCT06037447 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
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 |
|---|---|
| Ages | Any age to 14 Years |
| Sex | All |
| Enrollment | 256 (estimated) |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06037447 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with other significant cardiac malformations or conditions that contraindicate mitral valve surgery will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is innovative, similar studies have shown varying degrees of success in improving surgical outcomes in pediatric cardiac patients.
Who can join: the full rules
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 it's running
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Fuwai hospital
Beijing, Beijing, China Recruiting
Study contacts
- Study coordinator: Kai Ma, PhD
- Email: drmakaifw@yahoo.com
- Phone: +86 15901428497
Similar studies
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Evaluating the MITRIS RESILIA Mitral Valve in Asian Patients
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DragonFly EU Pivotal: Transcatheter mitral valve repair for mitral regurgitation
This trial tests the DragonFly transcatheter mitral valve repair system in adults with symptomatic moderate-to-severe or severe degenerative or functional mitral regurgitation who are high surgical risk or remain symptomatic after treatment.
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Evaluating a new device for repairing the mitral valve
This study is testing a new device to see if it can safely help people with severe mitral valve problems who can't have regular surgery.
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This study is looking at how well the NeoChord Artificial Chordae System works for people with degenerative mitral valve disease over five years, without needing any extra procedures beyond regular treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.