Ablation in Brugada Syndrome for the Prevention of VF

Study Overview
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Brief Summary
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This trial aims to develop evidence based curative treatment with optimal net benefit for patients with Brugada syndrome.

Detailed Description
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This trial aims to develop evidence based curative treatment with optimal net benefit for patients with Brugada syndrome. Since a recent non-randomized pilot study and scarce case reports documented potential clinical benefit of epicardial ablation of fragmented electrograms in the region of the right ventricular outflow tract, patients in this trial will be randomized to continued implanted cardioverter defibrillator therapy (control arm) or ablation of areas of fragmented electrograms in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy (intervention arm). A projected 92 patients in each group will be studied.

Official Title
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Ablation in Brugada Syndrome for Prevention of VF - A Randomized, Multi-center Study of Epicardial Ablation in Brugada Syndrome Patients to Prevent Arrhythmia Recurrence

Conditions
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Brugada Syndrome

Intervention / Treatment
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* Procedure: Catheter Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The diagnosis of Brugada syndrome is based on 2013 HRS/EHRA/APHRS Consensus document criteria Diagnosed symptomatic BrS with an implanted ICD within the last 5 years Diagnosed symptomatic BrS with an implanted ICD longer than 5 years but has at least 1 appropriate shock within the last 5 years The patient is legally competent, willing and able to undergo the study and signed the informed consent The patient is willing and able to adhere to the follow-up visit protocol Exclusion Criteria: A patient who does not meet inclusion criteria A patient who has had a previous epicardial ablation A patient who is pregnant (which would exclude an ablation procedure) A patient with a co-morbid condition that possesses undue risk of general anesthesia or epicardial ablation A patient who has a history of radiation therapy on the thorax

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 |
| --- | --- |
| No Intervention: Control arm<br>Control arm - continued implanted cardioverter defibrillator therapy | |
| Active Comparator: Intervention Arm<br>ablation of areas of fragmented signal in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy | Procedure: Catheter Ablation<br>* catheter ablation of fragmented signal in the right ventricular outflow tract<br>|
| Other: Single Cross Over Arm<br>these patients were initially assigned to the control arm of the study. When these patients met the primary outcome of the study it is allowed for these patients to be included in the intervention arm and/or to start quinidine | Procedure: Catheter Ablation<br>* catheter ablation of fragmented signal in the right ventricular outflow tract<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom of Ventricular Fibrillation/Tachycardia Recurrences | Survival from ventricular fibrillation of shocked ventricular arrhythmias causing ICD discharge | 3 year followup | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom without drug | Freedom of shocked ventricular arrhythmias without the use of anti-arrhythmic drugs during 3 years of follow-up | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventricular arrhythmias, aborted cardiac arrest, cardiac death