Epicardial Ablation in Brugada Syndrome. An Extension Study of 500 BrS.Patients

Not Applicable

Recruiting

• Conditions: ECG Brugada Pattern
• Interventions: Procedure: Ablation

• Registration Number: NCT03106701
• Lead Sponsor: IRCCS Policlinico S. Donato

Brief Summary

This study represents an extension of a previous study (NCT02641431) on the acute and long-term benefit of epicardial ablation on elimination of both BrS-ECG pattern and VT/VF inducibility in 500 consecutive BrS patients.

Detailed Description

According to previous protocol (NCT02641431), 300 additional consecutive selected patients having an ICD implantation will be enrolled up to a total of 500 BrS patients. Echocardiography with cardiac deformation analysis, three-dimensional color-coded voltage, activation and duration electroanatomical maps before and after ajmaline (1mg/kg in 5 minutes) wiil determine the site and the size of the arrhythmogenic substrate as characterized by abnormally prolonged fragmented ventricular potentials and potential wall motion abnormalities. Primary endpoint will be identification and elimination of this electrophysiological substrate by RF applications leading to ECG pattern normalization and VT/VF non-inducibility before and after ajmaline. Patients will be followed up to 10 years after ablation by sequential 12-lead ECG and Holter recording, Echocardiography, ICD interrogation, VT/VF inducibility patterns before and after ajmaline test.

Study Timeline

• Study Start: 2017-03-14
• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-04-04
• Study First Posted: 2017-04-10
• Status Verified: 2023-09
• Primary Completion: 2023-09-28
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-10-02
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Symptomatic BrS patients with typical BrS-related symptoms (cardiac arrest or syncope) or without typical BrS-related symptoms (dizziness, palpitations, presyncope, dyspnea) ICD implantation, spontaneous or ajmaline-induced type 1 Br pattern.

Exclusion Criteria

• Age < 18 years, prior epicardial ablation, pregnancy, co-morbidities.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ablation	Ablation	Radiofrequency epicardial ablation

Primary Outcome Measures

Name	Time	Method
VT/VF inducibility	immediately after mapping and ablation	Programmed stimulation was achieved at twice the diastolic threshold and randomly performed at RV apex and RV outflow tract using up to 3 drive cycle lengths (from 600 to 350ms) and up to three extrastimuli (S2-S4) delivered from the apex and outflow tract of the right ventricle.
Absence of VT/VF	1,3,6,12,18,24,36,48,60,72,84,96,108,120 months after ablation	Absence of VT/VF by ICD interrogation
Type 1 BrS-ECG pattern elimination by epicardial ablation before and after ajmaline test.	1 day after ablation	Normalization of ECG pattern after elimination by radio-frequency ablation of all abnormal epicardial potentials

Secondary Outcome Measures

Name	Time	Method
Absence of Br Pattern and RV mechanical abnormalities using echo and cardiac deformation analysis before and after ajmaline test	3 months	Abolition of typical BrS-ECG pattern and RV mechanical abnormalities before and after ajmaline.
Absence of VA episodes at EP study	48 months up to 120 months	ICD interrogation
Absence of Br ECG pattern after ajmaline test	24 months	Normalization of 12-lead ECG recording at baseline and after ajmaline test
Absence of Br Pattern at ajmaline test	48 months	Normalization of 12-lead ECG recording at baseline and after ajmaline test
Absence of VA episodes	24 months	ICD interrogation

Trial Locations

Locations (1)

IRCCS Policlinico S. Donato; 🇮🇹 San Donato Milanese, Milano, Italy