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Not yet recruitingNCT07704346Updated Jul 15, 2026

Echo, ECG and Holter Findings After Fallot Repair in Children

An observational study in Post Tetralogy of Fallot Repair Arrhythmias and Echocardiographic Changes, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to participants aged 1 Day to 25 Years. Per ClinicalTrials.gov, last updated 2026-07-15.

Sponsored by Sohag University · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
40
Ages
1 Day to 25 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Post Tetralogy of Fallot Repair Arrhythmias and Echocardiographic Changes
03

In context

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 25 Years
Sexes eligible
All
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.

Inclusion criteria

  • Children and adolescents up to age of 25 years old who have undergone surgical repair of Tetralogy of Fallot.

Exclusion criteria

Exclusion Criteria:

  • Ptients above age of 25 years.
  • Children with other medical diseases.
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
40 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testechocardiography , 12-lead ECG and Holter ECG

    Holter 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.

  2. 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.

    Time frame: Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.

  3. Presence and frequency of arrhythmias on Holter ECG in patients post TOF repair

    Holter ECG helps in detection of arrhythmias as presence of ectopics

    Time frame: Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.

  4. 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.

  5. 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.

    Time frame: Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.

Secondary outcomes

  1. 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.

  2. 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.

07

Study locations

1 site
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07704346
Lead sponsor
Sohag University
Responsible party
Ahmed Fathy Ramdan (Echocardiographic, ECG and Holter Parameters in Pediatric Patients Post-surgical Fallot Repair, Sohag University) — Principal investigator
First posted
Jul 15, 2026
Start date
Jul 11, 2026 (estimated)
Primary completion
Oct 15, 2026 (estimated)
Completion
Nov 15, 2026 (estimated)
Last update
Jul 15, 2026

Study contacts

Ahmed Fathy Ramadan Ali
Contact
ah.fathi1379@gmail.com
+201055811841

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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