Epicardial Ablation in Brugada Syndrome

Electrical Substrate Elimination in Brugada Syndrome. Results in 135 Consecutive Patients

This prospective study evaluates the methodology and results of epicardial mapping/ablation in a large series of consecutive selected BrS patients and to verify if RFA could normalize the consequences of a genetic disease.

The present Registry is designed as a prospective, monocentric study. All patients referred to the Arrhythmology Department of IRCCS Policlinico San Donato Milanese, University- Hospital, for the management of BrS and fulfilling the selection criteria will be invited to participate in the study and will be asked their written consent to the participation in the trial.

Mapping and RFA procedure will be performed following a standardized procedure in hospital settings. Patients will be monitored for at least 3 days after procedure.

Before hospital discharge, echocardiography and 12-lead ECG will be performed in all patients. An ajmaline test will be systematically performed after the procedure and thereafter at 3, 6, and 12 months after ablation.

Patients will be followed up clinically after procedure as per normal clinical practice. Follow-up visits will be scheduled at 3, 6, and 12 months. 12-lead ECG and ICD interrogation will be performed at each follow-up visits. Patients will be instructed to immediately contact the center in case of symptoms suggestive of ventricular arrhythmias. Documentation for intercurrent events will be requested and collected.

Inclusion Criteria:

• Patients affected by Brugada Syndrome, profiled by genetic testing, with documented spontaneous or drug-induced type I BrS ECG pattern, with symptoms attributable to ventricular arrhythmias and presenting multiple documented arrhythmic episodes
• Patients with an ICD already implanted
• Patients referred to the center for an electrophysiological study and indication to a potential concomitant radio-frequency catheter ablation (RFA) of ventricular arrhythmia or ventricular fibrillation
• Age ≥ 18
• Willingness to attend follow-up examinations
• Written informed consent to the participation in the trial

Exclusion Criteria:

• Pregnancy or breast-feeding
• Patients with low arrhythmic risk (Brugada pattern III)
• Life expectancy < 12 months.