Bioabsorbable Occluder for Outlet VSD: Safety and Aortic Valve Effects
NCT07040579 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50
Last updated 2025-06-27
Summary
This study aims to evaluate the efficacy and safety of transcatheter bioabsorbable occluder closure in patients with outlet-type ventricular septal defect (outlet VSD), with a focus on assessing its impact on aortic valve function.
Conditions
- Congenital Heart Defects
- VSD
Interventions
- DEVICE
-
transcatheter closure of outlet VSDs with bioabsorbable occluders
Transcatheter closure of outlet ventricular septal defects using a bioabsorbable occluder (Shape Memory Alloy Ltd, Shanghai, China). Implantation is performed via femoral/transthoracic approach under echocardiographic guidance following standard interventional protocols.
Sponsors & Collaborators
-
First Affiliated Hospital of Guangxi Medical University
lead OTHER
Principal Investigators
-
Liuliu Huang, MD · First Affiliated Hospital of Guangxi Medical University
Eligibility
- Min Age
- 1 Year
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-30
- Primary Completion
- 2032-09-30
- Completion
- 2032-12-31
Countries
- China
Study Locations
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