Bioabsorbable Occluder for Outlet VSD: Safety and Aortic Valve Effects
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1+
SponsorFirst Affiliated Hospital of Guangxi Medical University
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- transcatheter closure of outlet VSDs with bioabsorbable occluders
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov