Bioabsorbable Occluder for Outlet VSD: Safety and Aortic Valve Effects
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- First Affiliated Hospital of Guangxi Medical University
- Trial code
- NCT07040579
- Record updated
- 27 June 2025
- Original description
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.Read full original descriptionShow less
Transcatheter Bioabsorbable Occluder Closure for Outlet Ventricular Septal Defect: Safety, Effectiveness and Impact on Aortic Valve Function
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.
Inclusion: Age ≥1 year and weight ≥10 kg; Outlet VSD without ventricular malalignment; Maximal defect diameter ≤12mm with subaortic rim ≤1mm and no ≥mild aortic regurgitation by by transthoracic or transesophageal echocardiography; Written informed consent.
Exclusion: Concurrent cardiac conditions requiring surgical correction; Severe pulmonary hypertension (PVR > 5 WU, assessed by right heart catheterization ); Active systemic infection within 1 month; Outlet VSD with a fibrous postero-inferior rim; Intracardiac thrombus; Pregnancy.