Echo, ECG and Holter Findings After Fallot Repair in Children

Echocardiographic, ECG and Holter Parameters in Pediatric Patients Post-surgical Fallot Repair

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Post Tetralogy of Fallot Repair Arrhythmias and Echocardiographic Changes
• Intervention / Treatment: Diagnostic test: echocardiography , 12-lead ECG and Holter ECG

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Ahmed Fathy Ramadan Ali; Phone Number: +201055811841; Email: ah.fathi1379@gmail.com

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University
    • Contact: Ahmed Fathy Ramadan Ali; Phone Number: +201055811841; Email: ah.fathi1379@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Children and adolescents up to 25 years old of both sexes who have undergone surgical repair of Tetralogy of Fallot and have no other medical diseases.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QRS duration on 12-lead ECG in patients post Tetralogy of Fallot surgical repair	QRS duration measured in milliseconds using a standard 12-lead electrocardiogram	Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.
Corrected QT interval (QTc) on 12-lead ECG in patients post TOF surgical repair	QTc is measured in milliseconds using standard 12-lead electrocardiogram to detect if it is prolonged or not.	Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.
Presence and frequency of arrhythmias on Holter ECG in patients post TOF repair	Holter ECG helps in detection of arrhythmias as presence of ectopics	Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.
Severity of pulmonary regurgitation by echocardiography in patients post TOF surgical repair		Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.
Right ventricular function by echocardiography in patients post Tetralogy of Fallot surgical repair	Right ventricular contractility and enlargement measured by echocardiography to detect if patient is in heart failure or not.	Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.

Secondary Outcome Measures

Outcome Measure	Time Frame
PR interval by 12-lead ECG in pediatric patients post Fallot surgical repair	Data will be collected over 1 year period starting after after approval of protocol by medical research committee of Sohag faculty of medicine.
Severity of tricusped regurgitation by echocardiography in pediatric patients post Fallot surgical repair.	Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Estimated): July 11, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): November 15, 2026

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Electrodiagnosis; Cardiac Imaging Techniques; Ultrasonography; Monitoring, Physiologic; Monitoring, Ambulatory; Electrocardiography; Echocardiography; Electrocardiography, Ambulatory
• Other Study ID Numbers: Soh-Med--25-9-4MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No