Bioabsorbable Occluder for Outlet VSD: Safety and Aortic Valve Effects

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Number of participants with procedural success — 12 months
  1. Occluder in correct anatomical position 2. Absence of major adverse events (all-cause mortality, all stroke, myocardial infarction, or re-hospitalization for device/procedure-related causes) 3) Residual shunt ≤ 2 mm and aortic regurgitation ≤ trace evaluated by transthoracic or transesophageal echocardiography

Trial sites (1)

More First Affiliated Hospital of Guangxi Medical University trials in China