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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    300
  • sponsor
    IRCCS Policlinico S. Donato
Updated on 25 February 2022

Summary

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.

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.

Details
Condition ECG Brugada Pattern
Treatment ablation
Clinical Study IdentifierNCT03106701
SponsorIRCCS Policlinico S. Donato
Last Modified on25 February 2022

Eligibility

Yes No Not Sure

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

Age < 18 years, prior epicardial ablation, pregnancy, co-morbidities
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