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NOT YET RECRUITING
NCT07040579

Bioabsorbable Occluder for Outlet VSD: Safety and Aortic Valve Effects

Sponsor: First Affiliated Hospital of Guangxi Medical University

View on ClinicalTrials.gov

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.

Official title: Transcatheter Bioabsorbable Occluder Closure for Outlet Ventricular Septal Defect: Safety, Effectiveness and Impact on Aortic Valve Function

Key Details

Gender

All

Age Range

1 Year - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2025-06-30

Completion Date

2032-12-31

Last Updated

2025-06-27

Healthy Volunteers

No

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.

Locations (1)

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China