Epicardial Ablation in Brugada Syndrome to Prevent Sudden Death
1 other identifier
interventional
150
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 10, 2017
CompletedFirst Submitted
Initial submission to the registry
September 22, 2017
CompletedFirst Posted
Study publicly available on registry
September 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedSeptember 29, 2023
September 1, 2023
6.1 years
September 22, 2017
September 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Survival from any VA recurrence will be considered as primary endpoint
NO ventricular arrhythmia recurrence
2 years after ablation
Study Arms (2)
Ablation plus ICD
ACTIVE COMPARATOREpicardial ablation by radio-frequency
ICD alone
ACTIVE COMPARATORImplantation of ICD
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Pregnancy or breast-feeding (which would exclude an ablation procedure);
- Contraindications to general anesthesia or epicardial ablation;
- Life expectancy \< 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Policlinico S. Donato
San Donato Milanese, Milano, 20097, Italy
Related Publications (1)
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.
PMID: 40401314DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlo Pappone, MD
IRCCS Policlinico San Donato Milan, Italy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Arrhythmology Department
Study Record Dates
First Submitted
September 22, 2017
First Posted
September 27, 2017
Study Start
September 10, 2017
Primary Completion
September 28, 2023
Study Completion
December 30, 2023
Last Updated
September 29, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share