Epicardial Ablation in Brugada Syndrome to Prevent Sudden Death

Study Overview
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Brief Summary
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A total of 150 patients will be randomized to perform catheter ablation or not in a 2:1 fashion in selected patients with Brugada-related symptoms (Ablation+ICD arm 105 patients vs ICD only 45 patients).

Detailed Description
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The main purpose of this trial is to develop evidence-based curative treatment with optimal net benefit for patients with Brugada syndrome. As recent non-randomized pilot studies and scarce case reports documented the potential benefit of epicardial ablation, patients in this trial will be randomized to epicardial catheter ablation of the regions exhibiting abnormally prolonged and fragmented electrograms in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy (ablation arm) or continued implanted cardioverter defibrillator therapy (control arm). Survival from any ventricular arrhythmia (VA) recurrence will be considered as primary endpoint. A projected 150 patients will be enrolled and randomized to receive ablation or not in a 2:1 fashion (Ablation+ICD arm 105 patients vs ICD only 45 patients).

Official Title
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Epicardial Ablation in Brugada Syndrome in the Prevention of Sudden Cardiac Death. A Randomized Prospective Follow-up Study.

Conditions
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Ventricular Arrhythmias and Cardiac Arrest

Intervention / Treatment
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* Other: ablation plus ICD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients affected by Brugada Syndrome diagnosed according to 2013 HRS/EHRA/APHRS Consensus document criteria The patient received at least 1 appropriate ICD shock. Documentation of any previous ventricular arrhythmia (VA) in the form of VT, non-sustained VT, non-sustained VF, RVOT PVC with a daily burden >10000; Age ≥ 18; Willingness to attend follow-up examinations; Written informed consent for participation in the trial. Exclusion Criteria: A patient who does not meet inclusion criteria; Pregnancy or breast-feeding (which would exclude an ablation procedure); Contraindications to general anesthesia or epicardial ablation; Life expectancy < 12 months

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ablation plus ICD<br>Epicardial ablation by radio-frequency | Other: ablation plus ICD<br>* Defibrillator, radio-frequency catheter ablation<br>|
| Active Comparator: ICD alone<br>Implantation of ICD | Other: ablation plus ICD<br>* Defibrillator, radio-frequency catheter ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival from any VA recurrence will be considered as primary endpoint | NO ventricular arrhythmia recurrence | 2 years after ablation |