Brugada Syndrome
Conditions
Keywords
Ventricular arrhythmias, aborted cardiac arrest, cardiac death
Brief summary
This trial aims to develop evidence based curative treatment with optimal net benefit for patients with Brugada syndrome.
Detailed description
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.
Interventions
PROCEDURECatheter Ablation
catheter ablation of fragmented signal in the right ventricular outflow tract
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Pacific Rim Electrophysiology Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom of Ventricular Fibrillation/Tachycardia Recurrences | 3 year followup | Survival from ventricular fibrillation of shocked ventricular arrhythmias causing ICD discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom without drug | 3 years | Freedom of shocked ventricular arrhythmias without the use of anti-arrhythmic drugs during 3 years of follow-up |
Countries
Netherlands, Thailand
Outcome results
None listed