Ventricular Arrhythmias and Cardiac Arrest
Conditions
Brief summary
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).
Detailed description
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).
Interventions
OTHERablation plus ICD
Defibrillator, radio-frequency catheter ablation
Sponsors
IRCCS Policlinico S. Donato
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
* Patients affected by Brugada Syndrome diagnosed according to 2013 HRS/EHRA/APHRS * Consensus document criteria * The patient received at least 1 appropriate ICD shock. * Documentation of any previous ventricular arrhythmia (VA) in the form of VT, non-sustained VT, non-sustained VF, RVOT PVC with a daily burden \>10000; * Age ≥ 18; * Willingness to attend follow-up examinations; * Written informed consent for participation in the trial.
Exclusion criteria
* A patient who does not meet inclusion criteria; * Pregnancy or breast-feeding (which would exclude an ablation procedure); * Contraindications to general anesthesia or epicardial ablation; * Life expectancy \< 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival from any VA recurrence will be considered as primary endpoint | 2 years after ablation | NO ventricular arrhythmia recurrence |
Countries
Italy
Contacts
Primary ContactCarlo Pappone, MD
Outcome results
None listed