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ACTIVE NOT RECRUITING
NCT05685134
NA

Epicardial Radiofrequency Catheter Ablation in Patients With Brugada Syndrome: a Randomized, Sham-controlled, Masked Clinical Trial

Sponsor: University of Sao Paulo General Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2020-11-03

Completion Date

2026-03

Last Updated

2026-03-23

Healthy Volunteers

No

Interventions

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

Locations (1)

Instituto do Coração - InCor - HC/FMUSP

São Paulo, São Paulo, Brazil