Outcome of Ablation of Tachyarrhythmias in Patients With Congenital Heart Diseases

Our observational study aim to to evaluate the incidence of Tachyarrhythmia in patients with congenital heart diseases (corrected/non corrected) and the effectiveness of catheter ablation.RF catheter ablation was performed to all patients and follow up for recurrence was done for one year.

Study Overview

• Status: Completed
• Conditions: Arrhythmia; Congenital Heart Disease; Ablation of Arrhythmias

Detailed Description

This is a prospective cohort observational study including patients with CHD undergoing attempted catheter ablation.Baseline information is collected before catheter ablation. Data include demographic characteristics (age, gender), type of CHD, dates and types of previous cardiac surgeries, comorbidities, Electrocardiographic (ECG) and ECG recordings Holter (24h to 7 days) during tachycardia to document arrhythmia type and the presence of resting pre-excitation, palpitations attacks (frequency, duration, ICU / ER admission, ECG and mode of termination), history of supraventricular and ventricular arrhythmias, pharmacological therapy, previous catheter ablation and cardiac imaging (echocardiography with or without cardiac magnetic resonance imaging or cardiac computed tomography).

RF catheter ablation is performed after obtaining informed consent from all patients. Antiarrhythmic medication is in most cases discontinued for at least five half-lives before the procedure. Prepping and draping are performed according to standard hospital protocols under complete local aseptic conditions. Variable sized sheaths are introduced percutaneously via the right/left femoral/Jugular/ subclavian vein. Under fluoroscopic guidance, three electrode catheters are positioned as follows: at the high right atrium, from the His bundle region to the right ventricle, and in the coronary sinus (CS) ostium region. Bipolar intracardiac electro grams filtered between 30 and 500 Hz along with the 12- lead surface ECG were simultaneously recorded and stored digitally on a computerized multichannel EP recording system. Cases are filtered according to complexity and availability of 3D to conventional group for simple cases where RF ablation will be done guided by Conventional fluoroscopic guidance and for complicated cases RF ablation is guided by 3d electro anatomical mapping system.

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

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11956
    • Cairo University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with congenital heart diseases (corrected / non corrected) with arrhythmia

Description

Inclusion Criteria:

• Patients with congenital heart diseases (corrected / non corrected) with documented arrhythmia
• Patients with congenital heart diseases without documented arrhythmia but frequent palpitations.

Exclusion Criteria:

• Pregnant
• Patients with unstable hemodynamics
• End stage diseases e.g.: cancer stage IV

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with congenital heart diseases with arrhythmia; Patients with congenital heart diseases (corrected / non corrected) with documented arrhythmia or without documented arrhythmia but frequent palpitations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of acute success of catheter ablation	defined as termination of the clinical arrhythmia with non-inducibility of this clinical arrhythmia during Catheter ablation	From timing of catheter ablation till about one hour
rate of recurrence of tachyarrhythmias after catheter ablation		one year

Secondary Outcome Measures

Outcome Measure	Time Frame
The types of Tachyarrhythmia in patients with congenital heart diseases	One year

Collaborators and Investigators

• Sponsor: Fayoum University

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2024
• Primary Completion (Actual): February 26, 2025
• Study Completion (Actual): February 28, 2026

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: May 2, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 2, 2026
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Outcome; Congenital heart disease, Catheter ablation, arrhythmia, Radiofrequency, 3D Mapping, tachycardia.
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Heart Defects, Congenital; Tachycardia; Arrhythmias, Cardiac
• Other Study ID Numbers: D366

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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