Post Tetralogy of Fallot Repair Arrhythmias and Echocardiographic ChangesNCT07704346
Echo, ECG and Holter Findings After Fallot Repair in Children
An observational study of Post Tetralogy of Fallot Repair Arrhythmias and Echocardiographic Changes, run by Sohag University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 1 day to 25 years
- Conditions the study is for
- Post Tetralogy of Fallot Repair Arrhythmias and Echocardiographic Changes
- What is being tested?
- echocardiography , 12-lead ECG and Holter ECG
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jul 2026to 15 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 25 years
- All sexes
- Child, Adult
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.
Who may be able to join
- Children and adolescents up to age of 25 years old who have undergone surgical repair of Tetralogy of Fallot.
Who cannot join
- Ptients above age of 25 years.
- Children with other medical diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag university
Sohag
Ahmed Fathy Ramadan Ali, +201055811841, ah.fathi1379@gmail.com
About this study
Official title: 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.
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.
- Being tested
- echocardiography , 12-lead ECG and Holter ECG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiography , 12-lead ECG and Holter ECGDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.
Secondary outcomes (2)
PR interval by 12-lead ECG in pediatric patients post Fallot surgical repair
Measured: 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.
Measured: Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start11 Jul 2026 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Tetralogy of Fallot Repair Arrhythmias and Echocardiographic ChangesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Fathy Ramdan, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704346
- Sponsor's protocol ID
- Soh-Med--25-9-4MS
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic, ECG and Holter Parameters in Pediatric Patients Post-surgical Fallot Repair
- ClinicalTrials.gov ID
- NCT07704346
- Acronym / sponsor ID
- Soh-Med--25-9-4MS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 11 Jul 2026 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 25 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- Children and adolescents up to age of 25 years old who have undergone surgical repair of Tetralogy of Fallot.
Key exclusion criteria (2 listed)
- Ptients above age of 25 years.
- Children with other medical diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| echocardiography , 12-lead ECG and Holter ECGHolter 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. | Diagnostic test | – |
Primary outcome
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
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.
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
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.
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.
2 secondary outcomes
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Tetralogy of Fallot Repair Arrhythmias and Echocardiographic Changes, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Fathy Ramadan Ali (+201055811841, ah.fathi1379@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.