Bioabsorbable Occluder for Outlet VSD: Safety and Aortic Valve Effects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcatheter closure of outlet VSDs with bioabsorbable occluders.
- Who it may be relevant to
- Registry conditions: Congenital Heart Defects, VSD. Basic parameters: from 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Transcatheter Bioabsorbable Occluder Closure for Outlet Ventricular Septal Defect: Safety, Effectiveness and Impact on Aortic Valve Function
Overview
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.
Detailed description
Outflow-type ventricular septal defects (outlet VSDs) represent a challenging subset of congenital heart defects due to their association with progressive aortic valve prolapse and regurgitation. While surgical repair remains the gold standard, no reliable occluder has been available for transcatheter closure of this defect subtype.
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.
Interventions
- Device 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.
Primary outcome measures
- Number of participants with procedural success [Time frame: 12 months]
Secondary outcome measures (8)
- Number of participants with technical success [Time frame: Intraprocedural]
- Number of participants with major adverse events [Time frame: 12/24/60 months]
- Closure Efficacy [Time frame: Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months]
- Aortic regurgitation severity [Time frame: Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months]
- Pulmonary regurgitation severity [Time frame: Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months]
- Left ventricular outflow tract (LVOT) velocity and pressure gradient [Time frame: Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months]
- Right ventricular outflow tract （RVOT）velocity and pressure gradient [Time frame: Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months]
- Disc area quantification [Time frame: 72 hours post procedure, 1/3/6/12/24/60 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Affiliated Hospital of Guangxi Medical University — Nanning
Identifiers
NCT: NCT07040579 · GXMU-VSDO-001