This trial aims to develop evidence based curative treatment with optimal net benefit for patients with Brugada syndrome.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
catheter ablation of fragmented signal in the right ventricular outflow tract
Academic Medical Center, University of Amsterdam
Amsterdam, Netherlands
Bhumipol Adulyadej Hospital, Royal Thai Air Force
Bangkok, Thailand
Chulalongkorn University
Bangkok, Thailand
Pacific Rim Electrophysiology Research Institute Data Coordinating Center
Bangkok, Thailand
Freedom of Ventricular Fibrillation/Tachycardia Recurrences
Survival from ventricular fibrillation of shocked ventricular arrhythmias causing ICD discharge
Time frame: 3 year followup
Freedom without drug
Freedom of shocked ventricular arrhythmias without the use of anti-arrhythmic drugs during 3 years of follow-up
Time frame: 3 years
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Ramathibodi Hospital
Bangkok, Thailand
Chiang Mai University
Chiang Mai, Thailand