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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ablation plus ICD | Active Comparator | Epicardial ablation by radio-frequency |
|
| ICD alone | Active Comparator | Implantation of ICD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ablation plus ICD | Other | Defibrillator, radio-frequency catheter ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival from any VA recurrence will be considered as primary endpoint | NO ventricular arrhythmia recurrence | 2 years after ablation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlo Pappone, MD | Contact | +39 02 52774260 | carlo.pappone@af-ablation.org |
| Name | Affiliation | Role |
|---|---|---|
| Carlo Pappone, MD | IRCCS Policlinico San Donato Milan, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Policlinico S. Donato | Recruiting | San Donato Milanese | Milano | 20097 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40401314 | Derived | Pappone C, Ciconte G, Vicedomini G, Micaglio E, Boccellino A, Negro G, Giannelli L, Rondine R, Creo P, Tarantino A, Ballarotto M, Maiolo V, Ciaccio C, Manuello R, Locati ET, Mazza BC, Vecchi M, Calovic Z, Anastasia L. Epicardial ablation in high-risk Brugada syndrome to prevent ventricular fibrillation: results from a randomized clinical trial. Europace. 2025 May 7;27(5):euaf097. doi: 10.1093/europace/euaf097. |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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