Sohag university
Sohag, Egypt
Not Yet Recruiting
NCT Number: NCT07704346
Echo, ECG and Holter Findings After Fallot Repair in Children
Aim of my study is to detect echocardiographic, ECG and Holter changes in children who have undergone surgical repair of Tetralogy of Fallot. It is a retrospective observational study which will be conducted in Sohag university hospital. Age group of patients included in the study varying from 1 day up to 25 years old.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Age range
1 day–25 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
Aim of my study is to detect echocardiographic, ECG and Holter changes in children who have undergone surgical repair of Tetralogy of Fallot. This will be done by history taking of having chest pain , palpitations or any other cardiac symptoms then general and cardiac examination then performing 12-lead ECG and Holter ECG to detect any arrhythmias. Echocardiography will be also done to detect presence of pulmonary or tricuspid regurgitation, ventricular dilatation or pulmonary stenosis. The study is a retrospective observational study. Age group of patients varying from 1 day up to 25 years old.
Who can participate
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Children and adolescents up to age of 25 years old who have undergone surgical repair of Tetralogy of Fallot.
Exclusion criteria
- Ptients above age of 25 years.
- Children with other medical diseases.
Treatment and study plan
echocardiography , 12-lead ECG and Holter ECG
Diagnostic TestHolter ECG is used for recording electrocardiogram for long duration varying from hours to days. Echocardiography is used for detecting anatomical and functional defects in the heart.
Primary outcomes
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QRS duration on 12-lead ECG in patients post Tetralogy of Fallot surgical repair
Time frame: Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.
QRS duration measured in milliseconds using a standard 12-lead electrocardiogram
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Corrected QT interval (QTc) on 12-lead ECG in patients post TOF surgical repair
Time frame: Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.
QTc is measured in milliseconds using standard 12-lead electrocardiogram to detect if it is prolonged or not.
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Presence and frequency of arrhythmias on Holter ECG in patients post TOF repair
Time frame: Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.
Holter ECG helps in detection of arrhythmias as presence of ectopics
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Severity of pulmonary regurgitation by echocardiography in patients post TOF surgical repair
Time frame: Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.
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Right ventricular function by echocardiography in patients post Tetralogy of Fallot surgical repair
Time frame: Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.
Right ventricular contractility and enlargement measured by echocardiography to detect if patient is in heart failure or not.
Secondary outcomes
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PR interval by 12-lead ECG in pediatric patients post Fallot surgical repair
Time frame: Data will be collected over 1 year period starting after after approval of protocol by medical research committee of Sohag faculty of medicine.
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Severity of tricusped regurgitation by echocardiography in pediatric patients post Fallot surgical repair.
Time frame: Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Sohag University
Other
Registry information
Official study title
Echocardiographic, ECG and Holter Parameters in Pediatric Patients Post-surgical Fallot Repair
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jul 15, 2026
- Registry last updated
- Jul 15, 2026
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.