Epicardial Ablation in Brugada Syndrome. An Extension Study of 500 BrS.Patients

San Donato Group (GSD)

Status

Enrolling

Conditions

ECG Brugada Pattern

Treatments

Procedure: Ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT03106701

IRCCSDonato

Details and patient eligibility

About

This study represents an extension of a previous study (NCT02641431) on the acute and long-term benefit of epicardial ablation on elimination of both BrS-ECG pattern and VT/VF inducibility in 500 consecutive BrS patients.

Full description

According to previous protocol (NCT02641431), 300 additional consecutive selected patients having an ICD implantation will be enrolled up to a total of 500 BrS patients. Echocardiography with cardiac deformation analysis, three-dimensional color-coded voltage, activation and duration electroanatomical maps before and after ajmaline (1mg/kg in 5 minutes) wiil determine the site and the size of the arrhythmogenic substrate as characterized by abnormally prolonged fragmented ventricular potentials and potential wall motion abnormalities. Primary endpoint will be identification and elimination of this electrophysiological substrate by RF applications leading to ECG pattern normalization and VT/VF non-inducibility before and after ajmaline. Patients will be followed up to 10 years after ablation by sequential 12-lead ECG and Holter recording, Echocardiography, ICD interrogation, VT/VF inducibility patterns before and after ajmaline test.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Symptomatic BrS patients with typical BrS-related symptoms (cardiac arrest or syncope) or without typical BrS-related symptoms (dizziness, palpitations, presyncope, dyspnea) ICD implantation, spontaneous or ajmaline-induced type 1 Br pattern.

Exclusion criteria