Brugada Syndrome
Conditions
Keywords
radiofrequency ablation, mapping, sudden death, syncope
Brief summary
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.
Detailed description
The present Registry is designed as a prospective, monocentric study. All patients referred to the Arrhythmology Department of IRCCS Policlinico San Donato Milanese, University- Hospital, for the management of BrS and fulfilling the selection criteria will be invited to participate in the study and will be asked their written consent to the participation in the trial. Mapping and RFA procedure will be performed following a standardized procedure in hospital settings. Patients will be monitored for at least 3 days after procedure. Before hospital discharge, echocardiography and 12-lead ECG will be performed in all patients. An ajmaline test will be systematically performed after the procedure and thereafter at 3, 6, and 12 months after ablation. Patients will be followed up clinically after procedure as per normal clinical practice. Follow-up visits will be scheduled at 3, 6, and 12 months. 12-lead ECG and ICD interrogation will be performed at each follow-up visits. Patients will be instructed to immediately contact the center in case of symptoms suggestive of ventricular arrhythmias. Documentation for intercurrent events will be requested and collected.
Interventions
PROCEDUREmapping/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
DRUGAjmaline
Epicardial mapping will be performed before and after ajmaline (1mg/Kg in 5 minutes).
PROCEDUREablation
Radiofrequency will be delivered on areas of the abnormal electrograms using an externally irrigated 3.5-mm tip ablation catheter.
PROCEDUREmapping
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.
Sponsors
IRCCS Policlinico S. Donato
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Pregnancy or breast-feeding * Patients with low arrhythmic risk (Brugada pattern III) * Life expectancy \< 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absence of the ECG Br pattern | 1 day | Disappearance of the BrS-ECG pattern before and after ajmaline immediately after epicardial ablation and at discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absence of episodes of ventricular arrhythmias | 3 months after procedure | Absence of ECG Br pattern and arrhythmic episodes as documented by ICD interrogation, particularly in patients with worst clinical presentation and frequent ICD discharges |
| Complications | 1 day | Acute complications during and after the procedure will be evaluated clinically. Potential pericardial damage will be evaluated clinically and by Echocardiography. |
| Long-term complications | 3 months | Long-term complications will be evaluated 3 months after the procedure clinically and by echocardiography |
Countries
Italy
Outcome results
None listed