Congenital Heart DiseaseNCT07574931
Outcome of Ablation of Tachyarrhythmias in Patients With Congenital Heart Diseases
An observational study of Congenital Heart Disease and Arrhythmia, run by Fayoum University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Congenital Heart Disease, Arrhythmia, Ablation of Arrhythmias
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Apr 2024to 28 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with congenital heart diseases (corrected / non corrected) with arrhythmia
Who may be able to join
- Patients with congenital heart diseases (corrected / non corrected) with documented arrhythmia
- Patients with congenital heart diseases without documented arrhythmia but frequent palpitations.
Who cannot join
- Pregnant
- Patients with unstable hemodynamics
- End stage diseases e.g.: cancer stage IV
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Keywords
- Congenital heart disease, Catheter ablation, arrhythmia, Radiofrequency, 3D Mapping, tachycardia., Outcome
- Medical subject headings
- Heart Defects, Congenital, Arrhythmias, Cardiac, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From timing of catheter ablation till about one hour
rate of recurrence of tachyarrhythmias after catheter ablation
Measured: one year
Secondary outcomes (1)
The types of Tachyarrhythmia in patients with congenital heart diseases
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start16 Apr 2024
- Primary completion26 Feb 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Fayoum 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Mahmoud Mohamed Ibrahim, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574931
- Sponsor's protocol ID
- D366
- Status last verified
- Apr 2024
- First submitted
- 21 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Ablation of Tachyarrhythmias in Patients With Congenital Heart Diseases
- ClinicalTrials.gov ID
- NCT07574931
- Acronym / sponsor ID
- D366
- Keywords
- Congenital heart disease, Catheter ablation, arrhythmia, Radiofrequency, 3D Mapping, tachycardia., Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 8 May 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with congenital heart diseases (corrected / non corrected) with arrhythmia
Key inclusion criteria (2 listed)
- Patients with congenital heart diseases (corrected / non corrected) with documented arrhythmia
- Patients with congenital heart diseases without documented arrhythmia but frequent palpitations.
Key exclusion criteria (3 listed)
- Pregnant
- Patients with unstable hemodynamics
- End stage diseases e.g.: cancer stage IV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the rate of acute success of catheter ablation
Time frame: From timing of catheter ablation till about one hour
defined as termination of the clinical arrhythmia with non-inducibility of this clinical arrhythmia during Catheter ablation
rate of recurrence of tachyarrhythmias after catheter ablation
Time frame: one year
1 secondary outcome
The types of Tachyarrhythmia in patients with congenital heart diseases
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Congenital Heart Disease and Arrhythmia, run by Fayoum 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 8 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of acute success of catheter ablation (time frame: From timing of catheter ablation till about one hour). The study lists 2 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 8 May 2026.