NCT05685134

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Brugada Syndrome

Interventions

Type	Name	Description
DEVICE	Radiofrequency catheter ablation	Radiofrequency application via catheter to burn the electroanatomic substrate implicated in Brugada syndrome
DEVICE	Sham procedure	Venous and epicardial punctions, catheter insertions, programmed electrical stimulation and electroanatomical mapping

Timeline

• Start date: 2020-11-03
• Primary completion: 2026-04-07
• Completion: 2026-04-07
• First posted: 2023-01-13
• Last updated: 2026-04-14

Locations

1 site across 1 country: Brazil