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临床试验/NCT05540769
NCT05540769招募中不适用

Holter and ECG Changes After Transcatheter Closure Of ASD In Children

Sohag University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
ECG changes before and after the catheter guided ASD device closure

研究概览

简要总结

Atrial septal defects (ASD) account for 10% of all congenital heart defects [1].

Hemodynamic consequences of an ASD are dilatation of the right atrium and right ventricle (RV) because of the volume overload due to the left-to-right shunt through the ASD.For several decades, surgical closure has been considered the standard method of repairing a secundum ASD [2]. Surgical repair, albeit enjoying a high success rate, negligible mortality, and good long-term outcome, is associated with morbidity, discomfort, and thoracotomy scars [3]. That is why the transcatheter closure of the ASD has more recently become an alternative to the surgical procedure [4].

During the last decade , ASD device closure , has finally replaced surgical ASD repair in most patients as the standard method of repair for the secundum ASD[5,6].

Cardiac arrhythmias and right chamber enlargement are well known long-term sequelae of atrial septal defect (ASD) [7]. Therefore, many authors suggest ASD closure before adulthood [8,9].

Classical ECG findings for a significant ASD are prolongation of the PR interval, prolongation of the QRS duration and right axis deviation of the QRS [10].

Percutaneous ASD closure is an ideal situation to study changes of RV dimensions and their impact on ECG as interferences from cardiopulmonary bypass, cardiac incisions and sutures on the right atrium and on the interatrial septum are excluded[11].

详细描述

The Aim Of Work:

The focus of this study is to describe the electrocardiography (ECG) changes 1,6,12 months after ASD transcatheter device closure in a pediatric population.

Patients and Method:

  • Place of the Study: Cardiac catheterization unit , pediatric department , Sohag university hospital .
  • Type of the Study: Prospective observational study.
  • Study Period: 12 months (starting from the date of obtaining the approval from the research ethics committee) .
  • Patients:
  • Inclusion Criteria:
  • All children under the age of 18 years diagnosed with ASD , that will undergo transcatheter secundum ASD device closure during the period of the study .
  • Exclusion Criteria:
  • Failure to obtain informed consent .

Ethical consideration Approval will be obtained from the medical research ethics committee (MREC) of faculty of medicine Sohag university .Informed consent will be obtained from parent or authorized legal representative of all children included in the study .

研究设计

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

入排标准

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

入选标准

  • - All children under the age of 18 years diagnosed with ASD , that will undergo transcatheter secundum ASD device closure during the period of the study .

排除标准

  • - Failure to obtain informed consent .

结局指标

主要结局

ECG changes before and after the catheter guided ASD device closure

时间窗: 1 month , 6 months , 1 year

12 leads ECG (Fukuda Denshi CardiMax ECG device model FCP-7101 with a 25 mm/s paper speed, gain 10 mm/mV) the day before and the day after the procedure ECG PR interval , ECG QRS interval , ECG axis , and ECG corrected QT interval "QTc" will be recorded .

Holter ECG changes before and after the ASD closure

时间窗: 1 month , 6 months , 1 year

Holter ECG (Mortara H3+ Holter ECG) changes the day before and the day after the procedure. ECG PR interval , ECG QRS interval , ECG axis , and ECG corrected QT interval "QTc" will be recorded .

ECG changes in Heart rate [HR] before and after the catheter guided ASD device closure

时间窗: 1 month , 6 months , 1 year

12 leads ECG (Fukuda Denshi CardiMax ECG device model FCP-7101 with a 25 mm/s paper speed, gain 10 mm/mV) the day before and the day after the procedure -Heart rate \[HR\]

Holter ECG changes in Heart rate [HR] before and after the ASD closure

时间窗: 1 month , 6 months , 1 year

Holter ECG (Mortara H3+ Holter ECG) changes the day before and the day after the procedure. Heart rate \[HR\]

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

Marwa Ahmed Abdel Galil

resident doctor at pediatric department at faculty of medicine sohag university hospital

Sohag University

研究点 (1)

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