Status:
UNKNOWN
Study of Innovative Drug Treatment Therapy for Pediatric Mitral Regurgitation
Lead Sponsor:
China National Center for Cardiovascular Diseases
Collaborating Sponsors:
Shanghai Children's Medical Center
Chinese Academy of Medical Sciences, Fuwai Hospital
Conditions:
Congenital Mitral Insufficiency
Eligibility:
All Genders
Up to 14 years
Brief Summary
The goal of this observational study is to compare the safety and effectiveness of a modified drug therapy with traditional drug therapy in pediatric patients with mild to moderate mitral valve regurg...
Eligibility Criteria
Inclusion
- \< 14 years old
- had not undertake mitral valve surgery before
- moderate to severe mitral regurgitation
Exclusion
- 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
- moderate to severe mitral regurgitation requires mitral valve surgery
Key Trial Info
Start Date :
April 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT06037434
Start Date
April 1 2022
End Date
December 31 2024
Last Update
September 15 2023
Active Locations (1)
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1
Fuwai hospital
Beijing, Beijing Municipality, China, 100037