Not Yet RecruitingNot Applicable

Bioabsorbable Occluder for Outlet VSD: Safety and Aortic Valve Effects

China50 participantsStarted 2025-06-30

Plain-language 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.

Who can participate

Age range1 Year

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * Outlet VSD with a fibrous postero-inferior rim * Concurrent cardiac conditions requiring surgical correction * Severe pulmonary hypertension (PVR \> 5 WU, assessed by right heart catheterization ) * Intracardiac thrombus * Pregnancy * Active systemic infection within 1 month

What they're measuring

Number of participants with procedural success

Timeframe: 12 months

Trial details

NCT IDNCT07040579

SponsorFirst Affiliated Hospital of Guangxi Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2032-09-30

Contact for this trial

Liuliu Huang, MD

+8618577780131 dochuangllgxnn@gmail.com

View on ClinicalTrials.gov More Congenital Heart Defects trials