Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome (NCT05685134) | Clinical Trial Compass
CompletedNot Applicable
Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome
Brazil20 participantsStarted 2020-11-03
Plain-language summary
This randomized, sham-controlled, and blinded clinical trial aims to evaluate the effects of radiofrequency catheter ablation on the phenotypic expression of patients with Brugada syndrome. The main questions it seeks to address are:
* What are the immediate effects of radiofrequency catheter ablation on cardiac electrophysiology?
* Is substrate-directed radiofrequency catheter ablation safe for patients with Brugada syndrome?
* Is substrate-directed epicardial radiofrequency catheter ablation effective in normalizing the electrocardiographic pattern and preventing life-threatening arrhythmic events?
Researchers will compare the ablation group with the control group to determine if there are differences in clinical and invasive markers of the disease after one year of follow-up.
Who can participate
Age range
18 Years – 70 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:
* Patients with a type 1 Brugada ECG pattern, as characterized by ST-segment elevation (≥2mm) with upward concavity associated with T-wave inversion, in at least one of the right precordial leads, positioned at the second, third or fourth intercostal space, either spontaneously or induced by a provocative test with Class I anti-arrhythmic drugs according to Vaughan Williams
* Patients clinically stable for at least six months before the enrollment
* Able to cope with follow-up visits up to one year after the intervention
* Patients who have signed the written informed consent
Exclusion Criteria:
* Pregnant women
* Patients with structural heart disease
* Patients with a known cardiac or systemic autonomic disorder
* Patients with a history of previous right ventricular outflow tract ablation
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
Activation recovery interval (ARI)
Timeframe: First 30 minutes after the intervention
2
Area of abnormal electrical potentials measured in square centimeters (cm²)
Timeframe: First 30 minutes after the intervention