Epicardial Ablation in Brugada Syndrome

NACompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

November 16, 2015

Primary Completion Date

December 21, 2016

Study Completion Date

December 30, 2016

Conditions
Brugada Syndrome
Interventions
PROCEDURE

mapping/ablation

Mapping/ablation procedures will be performed under general anesthesia. After femoral venous access and percutaneous epicardial access, a multipolar catheter will be positioned at the right ventricle apex. High-density endocardial and epicardial electroanatomical maps will be performed using the CARTO3 system to define areas of delayed fragmented prolonged potentials during stable sinus rhythm and during spontaneous or ajmaline-induced type 1 BrS ECG pattern. Ajmaline (1mg/Kg in 5 minutes) will be used for the provocative test. Complete endo and epicardial maps will be obtained to ensure reconstruction of a 3-dimensional geometry of the cardiac chambers and to identify areas of abnormal electrograms as characterized by prolonged fragmented ventricular signals

DRUG

Ajmaline

Epicardial mapping will be performed before and after ajmaline (1mg/Kg in 5 minutes).

PROCEDURE

ablation

Radiofrequency will be delivered on areas of the abnormal electrograms using an externally irrigated 3.5-mm tip ablation catheter.

PROCEDURE

mapping

A re-map focusing on the targeted area will be obtained after ablation. Re-mapping and ajmaline reinfusion will be used to confirm the elimination of all the abnormal electrogram and BrS-ECG pattern disappearance.

Trial Locations (1)

20097

IRCCS Policlinico S. Donato, San Donato Milanese

All Listed Sponsors
lead

IRCCS Policlinico S. Donato

OTHER

NCT02641431 - Epicardial Ablation in Brugada Syndrome | Biotech Hunter | Biotech Hunter