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Not yet recruiting NCT07704346

Echo, ECG and Holter Findings After Fallot Repair in Children

— Observational Post Tetralogy of Fallot Repair Arrhythmias and Echocardiographic Changes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: echocardiography , 12-lead ECG and Holter ECG.
Who it may be relevant to
Registry conditions: Post Tetralogy of Fallot Repair Arrhythmias and Echocardiographic Changes. Basic parameters: 1 Day — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
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Official title

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

Overview

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.

Interventions

  • Diagnostic test echocardiography , 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.

Primary outcome measures

  • 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.]
  • 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.]
  • 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.]
  • 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.]
Secondary outcome measures (2)
  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

Egypt · 1 center
  • Sohag university — Sohag

Identifiers

NCT: NCT07704346 · Soh-Med--25-9-4MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗