This prospective study evaluates the methodology and results of epicardial mapping/ablation
in a large series of consecutive selected BrS patients and to verify if RFA could normalize
the consequences of a genetic disease.
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Full eligibility criteria for NCT02641431
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Patients affected by Brugada Syndrome, profiled by genetic testing, with documented spontaneous or drug-induced type I BrS ECG pattern, with symptoms attributable to ventricular arrhythmias and presenting multiple documented arrhythmic episodes
Patients with an ICD already implanted
Patients referred to the center for an electrophysiological study and indication to a potential concomitant radio-frequency catheter ablation (RFA) of ventricular arrhythmia or ventricular fibrillation
Age ≥ 18
Willingness to attend follow-up examinations
Written informed consent to the participation in the trial
Pregnancy or breast-feeding
Patients with low arrhythmic risk (Brugada pattern III)
Life expectancy < 12 months.
All locations for NCT02641431
IRCCS Policlinico S. Donato
San Donato Milanese, Milano, Italy, 20097
View full eligibility
Tris trial is registered with FDA with number: NCT02641431. The sponsor of the trial is IRCCS Policlinico S. Donato and it is looking for 135 volunteers for the current phase.
Official trial title: Electrical Substrate Elimination in Brugada Syndrome. Results in 135 Consecutive Patients
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