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Completed

NCT Number: NCT06197191

Holter and ECG Changes After Trancatheter Closure Of ASD In Children

Atrial septal defects (ASD) account for 10% of all congenital heart defects . 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 . Surgical repair, albeit enjoying a high success rate, negligible mortality, and good long-term outcome, is associated with morbidity, discomfort, and thoracotomy scars. That is why the transcatheter closure of the ASD has more recently become an alternative to the surgical procedure . 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 Cardiac arrhythmias and right chamber enlargement are well known long-term sequelae of atrial septal defect (ASD) . Therefore, many authors suggest ASD closure before adulthood . 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 .

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

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Key information

Conditions

ASD II

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag University Hospital

Sohag, Sohag Governorate, Egypt

Who can participate

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Fukuda Denshi Cardimax ECG device model FCP-7101

Device

ecg and holter will be done one day before and one day after then after 1,6,12 month after transcatheter closure of ASD

Other names: Holter ECG mortara H3+

Primary outcomes

  1. ECG Changes after transcatheter closure of ASD

    Time frame: one year

    ECG will be done one day before and one day after then after 1,6,12 month of ASD closure , determination of the following variables ; heart rate, QRS axis, PR interval , QRS duration and the QT interval . Interpretation of every ECG paper was done using specific centile tables for normal values of ECG waves and intervals according to age . ECG will be examined for any abnormal rhythm (heart block, ectopics ,supraventricular or ventricular tachycardia) .

  2. HOLTER ECG Changes after transcatheter closure of ASD

    Time frame: one year

    Six channel Holter ECG will be used for recording the day before , the day after the procedure then repeated at 1m,6m and 12m . the recordings will be used for evaluation of mean HR, Mean QTC interval duration .

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 9, 2024
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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