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Follow-up After Percutaneous Device Closure of Ventricular Septal Defects

2026年7月15日 更新者:Noran Hasan Megally、Assiut University

Outcomes and Short-term Follow-up After Percutaneous Device Closure of Ventricular Septal Defects: A Study From Two Tertiary Pediatric Cardiac Care Centers in Upper Egypt

Ventricular septal defects (VSDs) are the most common congenital heart defects, accounting for 30-40% of congenital cardiac anomalies. They result from an abnormal opening in the interventricular septum, leading to left-to-right shunting. Clinical presentation depends on defect size and pulmonary vascular resistance, ranging from asymptomatic small defects to heart failure symptoms in infancy, with older children developing exercise intolerance or pulmonary hypertension.

Although surgical closure has long been the standard treatment, percutaneous transcatheter device closure has emerged as a less invasive alternative for selected VSD types, particularly muscular and suitable perimembranous defects. This approach offers comparable efficacy with reduced morbidity and shorter hospital stays.

This bicentric study aims to evaluate procedural success, complications, and short-term outcomes of percutaneous VSD closure in paediatric patients from Upper Egypt, providing essential data to guide clinical practice and quality improvement in tertiary cardiac centres.

研究概览

详细说明

Ventricular septal defects (VSDs) are the most common congenital heart defects, accounting for 30-40% of congenital cardiac anomalies. They result from an abnormal opening in the interventricular septum, leading to left-to-right shunting. Clinical presentation depends on defect size and pulmonary vascular resistance, ranging from asymptomatic small defects to heart failure symptoms in infancy, with older children developing exercise intolerance or pulmonary hypertension.

Diagnosis is primarily established by transthoracic echocardiography, which accurately defines defect anatomy, shunt severity, ventricular function, and pulmonary artery pressures. Management is individualized according to hemodynamic significance, with small asymptomatic defects managed conservatively and significant defects requiring intervention following initial medical therapy.

Although surgical closure has long been the standard treatment, percutaneous transcatheter device closure has emerged as a less invasive alternative for selected VSD types, particularly muscular and suitable perimembranous defects. This approach offers comparable efficacy with reduced morbidity and shorter hospital stays.

Recent studies report high procedural success rates (95-98%) using evolving device technologies, including Amplatzer™ and newer asymmetric occluders. However, outcome data from developing regions remain limited, highlighting the need for population-specific evidence.

This bicentric study aims to evaluate procedural success, complications, and short-term outcomes of percutaneous VSD closure in paediatric patients from Upper Egypt, providing essential data to guide clinical practice and quality improvement in tertiary cardiac centres.

研究类型

观察性的

注册 (估计的)

85

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

不

取样方法

非概率样本

研究人群

Paediatric patients (age ≤18 years) undergoing percutaneous device closure of VSDs at the participating centres

描述

Inclusion Criteria:

  1. Age: 6 months to 18 years
  2. Confirmed diagnosis of VSD (perimembranous, muscular) by transthoracic echocardiography (TTE)
  3. Hemodynamically significant VSD with: (Imtiaz et al., 2023)

    • Pulmonary blood flow (Qp) to Systemic blood flow (Qs) ≥1.5:1, OR
    • Evidence of left ventricular volume overload, OR
    • Pulmonary arterial hypertension (PAH) with reversible pulmonary vascular resistance
  4. Suitable anatomy for device closure as assessed by TTE and/or transesophageal echocardiography (TEE)
  5. Adequate rim (≥2mm) from VSD edges to cardiac valves and conduction system (for perimembranous VSDs)
  6. Written informed consent from parents/legal guardians
  7. Assent from children ≥ 12 years (as appropriate

Exclusion Criteria:

  1. Active endocarditis or systemic infection
  2. Fixed, irreversible pulmonary arterial hypertension (pulmonary vascular resistance >8 Wood units/m² or ratio of pulmonary vascular resistance (Rp) to systemic vascular resistance (Rs) >0.5)
  3. Multiple VSDs not amenable to device closure
  4. VSD associated with complex congenital heart disease requiring surgical intervention
  5. Contraindication to antiplatelet therapy
  6. Known allergy to device materials (nickel-titanium alloy)
  7. Patient or family unwilling to comply with follow-up protocol
  8. Life expectancy <1 year due to non-cardiac conditions
  9. Body weight <5 kg (relative contraindication, case-by-case assessment)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Procedural success rate
大体时间:baseline
To evaluate the procedural success rate and immediate safety of percutaneous device closure of VSDs in paediatric patients.
baseline
Assess short-term complications
大体时间:baseline
To assess short-term complications, including residual shunts, rhythm disturbances (especially AV block), and device-related adverse events during follow-up up to 6 months
baseline
Predictors of success and complications
大体时间:baseline
To evaluate clinical, echocardiographic outcomes and compare predictors of success and complications between the two tertiary centres
baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2027年10月1日

研究完成 (估计的)

2028年8月1日

研究注册日期

首次提交

2026年7月15日

首先提交符合 QC 标准的

2026年7月15日

首次发布 (实际的)

2026年7月20日

研究记录更新

最后更新发布 (实际的)

2026年7月20日

上次提交的符合 QC 标准的更新

2026年7月15日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • Closure of VSD

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

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