Active — Not RecruitingNot 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 range18 Years – 70 Years

SexALL

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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

What they're measuring

Activation recovery interval (ARI)

Timeframe: First 30 minutes after the intervention

Area of abnormal electrical potentials measured in square centimeters (cm²)

Timeframe: First 30 minutes after the intervention

Trial details

NCT IDNCT05685134

SponsorUniversity of Sao Paulo General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-07