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).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Defibrillator, radio-frequency catheter ablation
IRCCS Policlinico S. Donato
San Donato Milanese, Milano, Italy
RECRUITINGSurvival from any VA recurrence will be considered as primary endpoint
NO ventricular arrhythmia recurrence
Time frame: 2 years after ablation
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