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Epicardial Ablation in Brugada Syndrome — BRUGADA_I  

Brugada Syndrome Clinical Trial

Official title:
Electrical Substrate Elimination in Brugada Syndrome. Results in 135 Consecutive Patients

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02641431
Study type Interventional
Source IRCCS Policlinico S. Donato
Contact
Status Completed
Phase N/A
Start date November 16, 2015
Completion date December 30, 2016
View Details
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