Validation of ECG-Based Ventricular Arrhythmia Localization Algorithms in Patients With Repaired … (NCT07607821) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Validation of ECG-Based Ventricular Arrhythmia Localization Algorithms in Patients With Repaired Tetralogy of Fallot
30 participantsStarted 2026-07
Plain-language summary
Doctors use patterns on heart rhythm tracings (ECGs) to predict where abnormal heart rhythms originate, but these prediction methods were developed in people with normal heart structure. Patients with repaired Tetralogy of Fallot have hearts that developed differently, and cardiologists do not know if these prediction methods work accurately for them. In this study, the investigators will test whether three commonly used prediction methods work in Tetralogy of Fallot patients by pacing the heart from known locations during an already-scheduled heart procedure and comparing the predicted location to the actual location. Participation adds approximately 15 minutes to the procedure and does not require additional visits. The results will help cardiologists understand whether current methods can be trusted when planning treatments for abnormal heart rhythms in this patient population, or whether new prediction methods need to be developed.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients \>/= 18 years with repaired tetralogy of Fallot with pulmonary stenosis scheduled for clinically-indicated diagnostic electrophysiology (EP) study.
Exclusion Criteria:
* Dextrocardia or mesocardia.
* Double outlet right ventricle.
* Tetralogy of Fallot with pulmonary atresia.
* Contraindication to femoral arterial access.
* Mechanical aortic prosthesis.
* Inability to provide informed consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Algorithm accuracy (%)
Timeframe: From enrollment to completion of the pacing protocol during their EP study.