Status:
UNKNOWN
Epicardial Ablation in Brugada Syndrome to Prevent Sudden Death
Lead Sponsor:
IRCCS Policlinico S. Donato
Conditions:
Ventricular Arrhythmias and Cardiac Arrest
Eligibility:
All Genders
18-80 years
Phase:
NA
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 patient...
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 repor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03294278
Start Date
September 10 2017
End Date
December 30 2023
Last Update
September 29 2023
Active Locations (1)
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1
IRCCS Policlinico S. Donato
San Donato Milanese, Milano, Italy, 20097