Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome

Electrophysiological and Clinical Effects of Subtrate-directed Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome: a Randomized, Sham-controlled, Masked Clinical Trial

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.

Brugada syndrome (BS) is a cardiac disorder characterized by a specific electrocardiographic pattern and an increased risk of cardiac arrhythmias and sudden death. Most arrhythmic events occur during periods of rest, fever, or situations of heightened vagal activity. Over the past decade, catheter ablation has emerged as a valuable and potentially curative treatment for patients with BS. However, there is limited knowledge of its mechanisms or of its long-term effects on clinical and invasive markers.

This single-center, randomized, sham-controlled, and masked pilot study aims to investigate the impact of catheter ablation in 20 patients with Brugada syndrome. Participants will be randomly assigned to either the ablation or control group in a 1:1 allocation ratio and will be clinically monitored for at least 12 months following the intervention.

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