Transcatheter Bioabsorbable Occluder Closure for Outlet Ventricular Septal Defect: Safety, Effectiveness and Impact on Aortic Valve Function
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of participants with procedural success
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of participants with procedural success
时间窗: 12 months
1. Occluder in correct anatomical position 2. Absence of major adverse events (all-cause mortality, all stroke, myocardial infarction, or re-hospitalization for device/procedure-related causes) 3) Residual shunt ≤ 2 mm and aortic regurgitation ≤ trace evaluated by transthoracic or transesophageal echocardiography
次要结局
- Number of participants with technical success(Intraprocedural)
- Number of participants with major adverse events(12/24/60 months)
- Closure Efficacy(Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months)
- Aortic regurgitation severity(Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months)
- Pulmonary regurgitation severity(Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months)
- Left ventricular outflow tract (LVOT) velocity and pressure gradient(Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months)
- Right ventricular outflow tract （RVOT）velocity and pressure gradient(Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months)
- Disc area quantification(72 hours post procedure, 1/3/6/12/24/60 months)