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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Epicardial Radiofrequency ablation
IRCCS Policlinico S. Donato
San Donato Milanese, Milano, Italy
RECRUITINGType 1 BrS-ECG pattern elimination by epicardial ablation before and after ajmaline test.
Normalization of ECG pattern after elimination by radio-frequency ablation of all abnormal epicardial potentials
Time frame: 1 day after ablation
VT/VF inducibility
Programmed stimulation was achieved at twice the diastolic threshold and randomly performed at RV apex and RV outflow tract using up to 3 drive cycle lengths (from 600 to 350ms) and up to three extrastimuli (S2-S4) delivered from the apex and outflow tract of the right ventricle.
Time frame: immediately after mapping and ablation
Absence of VT/VF
Absence of VT/VF by ICD interrogation
Time frame: 1,3,6,12,18,24,36,48,60,72,84,96,108,120 months after ablation
Absence of Br Pattern and RV mechanical abnormalities using echo and cardiac deformation analysis before and after ajmaline test
Abolition of typical BrS-ECG pattern and RV mechanical abnormalities before and after ajmaline.
Time frame: 3 months
Absence of VA episodes at EP study
Non-inducibility of VT/VT at programmed electrophysiological study
Time frame: 3 months
Absence of Br Pattern at ajmaline test
Normalization of 12-lead ECG recording and echo parameters at baseline and after ajmaline test
Time frame: 6 months
Absence of VA episodes
ICD interrogation
Time frame: 6 months
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Absence of VA episodes
ICD interrogation and ajmaline test
Time frame: 12 months
Absence of Br Pattern at ajmaline test
Normalization of 12-lead ECG recording and echo parameters at baseline and after ajmaline test
Time frame: 12 months
Absence of Br Pattern at ajmaline test
Normalization of 12-lead ECG recording at baseline and after ajmaline test
Time frame: 18 months
Absence of VA episodes
ICD interrogation
Time frame: 24 months
Absence of Br ECG pattern after ajmaline test
Normalization of 12-lead ECG recording at baseline and after ajmaline test
Time frame: 24 months
Absence of VA episodes at EP study
ICD interrogation
Time frame: 36 months
Absence of Br Pattern at ajmaline test
Normalization of 12-lead ECG recording at baseline and after ajmaline test
Time frame: 36 months
Absence of Br Pattern at ajmaline test
Normalization of 12-lead ECG recording at baseline and after ajmaline test
Time frame: 48 months
Absence of VA episodes at EP study
ICD interrogation
Time frame: 48 months up to 120 months