An interventional study of ablation plus ICD in Ventricular Arrhythmias and Cardiac Arrest, sponsored by IRCCS Policlinico S. Donato. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-29.
Sponsored by IRCCS Policlinico S. Donato · Not applicable, Interventional, and Treatment
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).
Exclusion Criteria:
Epicardial ablation by radio-frequency
Other: ablation plus ICD
Implantation of ICD
Other: ablation plus ICD
Defibrillator, radio-frequency catheter ablation
Survival from any VA recurrence will be considered as primary endpoint
NO ventricular arrhythmia recurrence
Time frame: 2 years after ablation
Plan to share: No
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IRCCS Policlinico S. Donato