Epicardial Ablation in Brugada Syndrome

Brugada Syndrome Clinical Trial

— BRUGADA_I  

Official title:

Electrical Substrate Elimination in Brugada Syndrome. Results in 135 Consecutive Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02641431
• Other study ID #: AR-01-2015
• Status: Completed
• Phase: N/A
• First received: November 11, 2015
• Last updated: January 13, 2018
• Start date: November 16, 2015
• Est. completion date: December 30, 2016

Study information

• Verified date: November 2017
• Source: IRCCS Policlinico S. Donato
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: December 30, 2016
• Est. primary completion date: December 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brugada Syndrome
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	IRCCS Policlinico S. Donato	San Donato Milanese	Milano

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Brugada J, Pappone C, Berruezo A, Vicedomini G, Manguso F, Ciconte G, Giannelli L, Santinelli V. Brugada Syndrome Phenotype Elimination by Epicardial Substrate Ablation. Circ Arrhythm Electrophysiol. 2015 Dec;8(6):1373-81. doi: 10.1161/CIRCEP.115.003220. — View Citation

Brugada P, Brugada J. Right bundle branch block, persistent ST segment elevation and sudden cardiac death: a distinct clinical and electrocardiographic syndrome. A multicenter report. J Am Coll Cardiol. 1992 Nov 15;20(6):1391-6. — View Citation

Nademanee K, Veerakul G, Chandanamattha P, Chaothawee L, Ariyachaipanich A, Jirasirirojanakorn K, Likittanasombat K, Bhuripanyo K, Ngarmukos T. Prevention of ventricular fibrillation episodes in Brugada syndrome by catheter ablation over the anterior righ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of the ECG Br pattern	Disappearance of the BrS-ECG pattern before and after ajmaline immediately after epicardial ablation and at discharge.	1 day
Secondary	Absence of episodes of ventricular arrhythmias	Absence of ECG Br pattern and arrhythmic episodes as documented by ICD interrogation, particularly in patients with worst clinical presentation and frequent ICD discharges	3 months after procedure
Secondary	Absence of episodes of ventricular arrhythmias	Absence of ECG BR pattern and arrhythmic episodes as documented by ICD particularly in patients with worst clinical presentation and frequent ICD discharges.	6 months after procedure
Secondary	Absence of episodes of ventricular arrhythmias	Absence of ECG Br pattern and arrhythmic episodes will be evaluated clinically as documented by ICD particularly in patients with worst clinical presentation and frequent ICD discharges.	12 months after procedure
Secondary	Complications	Acute complications during and after the procedure will be evaluated clinically. Potential pericardial damage will be evaluated clinically and by Echocardiography.	1 day
Secondary	Long-term complications	Long-term complications will be evaluated 3 months after the procedure clinically and by echocardiography	3 months