跳至主要内容
临床试验/NCT06761807
NCT06761807尚未招募不适用

Electrocardiographic and Electrophysiologic Changes After Percutaneous Closure of Atrial Septal Defect

Assiut University0 个研究点目标入组 65 人开始时间: 2025年1月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
65
主要终点
incidence of SAN dysfunction

研究概览

简要总结

Primary outcomes :

Determining the incidence of SAN and AVN dysfunction before and after percutaneous ASD closure Comparing ECG and EP parameters of SAN and AVN before and after percutaneous ASD closure

Secondary outcomes :

Assessing clinical, echocardiographic and procedural risk factors affecting the AVN function after ASD closure device implantation Determining the incidence of supraventricular arrhythmia inducibility before and after percutaneous ASD closure

详细描述

Atrial septal defects (ASDs) are one of the most common types of acyanotic congenital heart diseases, comprising 6-10% all congenital heart defects. They represent the most common congenital heart disease diagnosed during adulthood. Secundum ASD is a defect in the fossa ovalis (septum primum), or the superior limb of the septum secundum and is the most common type of ASD (80% of all ASDs).

ASD closure for secundum ASD is recommended regardless of symptoms in patients with evidence of right ventricular (RV) volume overload and no pulmonary arterial hypertension (PAH) or left ventricular (LV) disease. Percutaneous device closure has become the first choice for secundum defect closure in presence of a feasible morphology with a reported low risk of serious complications (≤1% of patients).

Subclinical electrocardiography (ECG) abnormalities, sinoatrial node (SAN) and atrioventricular node (AVN) conduction abnormalities have been reported in patients with ASDs. . The reported incidence of AVN block following ASD device closure varies widely from none up to 6.1%. High-grade AVN block after device closure typically occurs in the first 24-hour post-procedure and may mandates device removal for resolution of heart block.

The mechanism of AVN block after ASD device occlusion could be due to mechanical pressure on the AV node or edema related to trauma. Young age and large defect/device size may be a risk factor for AVN block. Deficient rims of the ASD may also have an impact on development of AVN block.

Whether or not there is a direct impact of ASD device closure on the functional properties of AVN and SAN is not well elucidated. Testing the electrocardiographic and electrophysiologic (EP) parameters of AVN and SAN before and after the procedure could obviously help understanding the real risk

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All patients presented with secundum ASD eligible for percutaneous transcatheter ASD closure at Assiut university heart hospital

排除标准

  • •No exclusion

研究组 & 干预措施

Incidence of AV node dysfunction after ASD Closure

Experimental

Determining the incidence of SAN and AVN dysfunction before and after percutaneous ASD closure Comparing ECG and EP parameters of SAN and AVN before and after percutaneous ASD closure

干预措施: Electrophysiology study of heart (Procedure)

结局指标

主要结局

incidence of SAN dysfunction

时间窗: baseline

Determining the incidence of SAN and AVN dysfunction before and after percutaneous ASD closure Comparing ECG and EP parameters of SAN and AVN before and after percutaneous ASD closure

incidence of AVN dysfunction

时间窗: baseline

incidence of AVN dysfunction before and after percutaneous ASD closure

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma Osama Ali Ezz el_deen

Resident doctor

Assiut University

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