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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Epicardial Ablation in 500 Consecutive Brugada Syndrome Patients

Conditions
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ECG Brugada Pattern

Intervention / Treatment
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* Procedure: Ablation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ablation<br>Radiofrequency epicardial ablation | Procedure: Ablation<br>* Epicardial Radiofrequency ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type 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 | 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. | immediately after mapping and ablation | 
| Absence of VT/VF | Absence of VT/VF by ICD interrogation | 1,3,6,12,18,24,36,48,60,72,84,96,108,120 months after ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 
| Absence of VA episodes at EP study | Non-inducibility of VT/VT at programmed electrophysiological study | 3 months | 
| Absence of Br Pattern at ajmaline test | Normalization of 12-lead ECG recording and echo parameters at baseline and after ajmaline test | 6 months | 
| Absence of VA episodes | ICD interrogation | 6 months | 
| Absence of VA episodes | ICD interrogation and ajmaline test | 12 months | 
| Absence of Br Pattern at ajmaline test | Normalization of 12-lead ECG recording and echo parameters at baseline and after ajmaline test | 12 months | 
| Absence of Br Pattern at ajmaline test | Normalization of 12-lead ECG recording at baseline and after ajmaline test | 18 months | 
| Absence of VA episodes | ICD interrogation | 24 months | 
| Absence of Br ECG pattern after ajmaline test | Normalization of 12-lead ECG recording at baseline and after ajmaline test | 24 months | 
| Absence of VA episodes at EP study | ICD interrogation | 36 months | 
| Absence of Br Pattern at ajmaline test | Normalization of 12-lead ECG recording at baseline and after ajmaline test | 36 months | 
| Absence of Br Pattern at ajmaline test | Normalization of 12-lead ECG recording at baseline and after ajmaline test | 48 months | 
| Absence of VA episodes at EP study | ICD interrogation | 48 months up to 120 months |