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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BioOccl-VSD | Patients with outlet ventricular septal defects undergoing transcatheter closure with bioabsorbable occluders. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcatheter closure of outlet VSDs with bioabsorbable occluders | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with procedural success |
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with technical success | Absence of mortality, correct positioning of the occluder into the proper anatomical location， aortic regurgitation≤ trace by transthoracic or transesophageal echocardiography | Intraprocedural |
| Number of participants with major adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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All consecutive patients diagnosed with outlet ventricular septal defects who undergo transcatheter closure with bioabsorbable occluders
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liuliu Huang, MD | Contact | +8618577780131 | dochuangllgxnn@gmail.com | |
| Ji Wu, MD | Contact | +8613978862109 | gxnnwuji@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Liuliu Huang, MD | First Affiliated Hospital of Guangxi Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | 530021 | China |
Individual participant data (IPD) would not be shared, according to local authority data privacy policy.
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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|
All-cause mortality, all stroke, myocardial infarction, re-hospitalization for device or procedure-related causes |
| 12/24/60 months |
| Closure Efficacy | 1）Successful closure: Rate of successful VSD closure (residual shunt ≤2 mm) assessed by transthoracic or transesophageal echocardiography. 2) Complete closure: Rate of complete closure (no residual shunt) assessed by transthoracic or transesophageal echocardiography. | Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months |
| Aortic regurgitation severity | Aortic regurgitation severity measured by transthoracic and/or transesophageal echocardiography. Assessment of aortic regurgitation severity according to current recommendations for valvular heart disease. | Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months |
| Pulmonary regurgitation severity | Pulmonary regurgitation severity measured by transthoracic and/or transesophageal echocardiography. Assessment of pulmonary regurgitation severity according to current recommendations for valvular heart disease. | Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months |
| Left ventricular outflow tract (LVOT) velocity and pressure gradient | Peak LVOT velocity (m/s) and maximum instantaneous pressure gradient (mmHg) measured by continuous-wave Doppler (CWD) echocardiography, using the simplified Bernoulli equation (ΔP = 4v²). | Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months |
| Right ventricular outflow tract （RVOT）velocity and pressure gradient | Peak LVOT velocity (m/s) and maximum instantaneous pressure gradient (mmHg) measured by continuous-wave Doppler (CWD) echocardiography, using the simplified Bernoulli equation (ΔP = 4v²). | Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months |
| Disc area quantification | Left and right disc areas are measured by transthoracic echocardiography (TTE) planimetry in parasternal short-axis (PSAX), apical long-axis (ALAX), and apical 5-chamber (A5C) views using QLAB 3DQ Advanced software (Philips). The mean disc area is derived from the average of three orthogonal transthoracic echocardiography measurements. | 72 hours post procedure, 1/3/6/12/24/60 months |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |