Bioabsorbable Occluder for Outlet VSD: Safety and Aortic Valve Effects
NCT ID: NCT07040579
Last Updated: 2025-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
50 participants
OBSERVATIONAL
2025-06-30
2032-12-31
Brief Summary
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Detailed Description
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The anatomical proximity of outlet VSDs to the aortic valve has historically limited transcatheter interventions. Conventional eccentric metal occluders require strict patient selection, typically being feasible only in cases with small defects and minimal aortic valve prolapse. Moreover, long-term concerns persist regarding metal devices' impact on aortic valve function.
Bioabsorbable occluders have been clinically available for perimembranous VSD closure. Their soft material properties minimize mechanical trauma to the aortic valve, while gradual resorption over time may eliminate permanent device-related complications. However, robust data regarding their efficacy, safety, and long-term impact on aortic valve function in outlet VSDs remain lacking.
This study aims to evaluate the short- and long-term outcomes of bioabsorbable occluder closure in outlet VSD patients, with a focus on defect closure rates and aortic valve function preservation.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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BioOccl-VSD
Patients with outlet ventricular septal defects undergoing transcatheter closure with bioabsorbable occluders.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Year
ALL
No
Sponsors
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First Affiliated Hospital of Guangxi Medical University
OTHER
Responsible Party
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Principal Investigators
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Liuliu Huang, MD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Guangxi Medical University
Locations
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The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GXMU-VSDO-001
Identifier Type: -
Identifier Source: org_study_id
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