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

ECG Brugada Pattern Clinical Trial

Official title:

Epicardial Ablation in 500 Consecutive Brugada Syndrome Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03106701
• Other study ID #: IRCCSDonato
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2017
• Est. completion date: December 30, 2023

Study information

• Verified date: September 2023
• Source: IRCCS Policlinico S. Donato
• Contact: Carlo Pappone, MD
• Phone: +39 02 52774260
• Email: carlo.pappone[@]af-ablation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 30, 2023
• Est. primary completion date: September 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brugada Syndrome
• ECG Brugada Pattern

Intervention

Procedure:
• Ablation
Epicardial Radiofrequency ablation

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type 1 BrS-ECG pattern elimination by epicardial ablation before and after ajmaline test.	Normalization of ECG pattern after elimination by radio-frequency ablation of all abnormal epicardial potentials	1 day after ablation
Primary	VT/VF inducibility	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.	immediately after mapping and ablation
Primary	Absence of VT/VF	Absence of VT/VF by ICD interrogation	1,3,6,12,18,24,36,48,60,72,84,96,108,120 months after ablation
Secondary	Absence of Br Pattern and RV mechanical abnormalities using echo and cardiac deformation analysis before and after ajmaline test	Abolition of typical BrS-ECG pattern and RV mechanical abnormalities before and after ajmaline.	3 months
Secondary	Absence of VA episodes at EP study	Non-inducibility of VT/VT at programmed electrophysiological study	3 months
Secondary	Absence of Br Pattern at ajmaline test	Normalization of 12-lead ECG recording and echo parameters at baseline and after ajmaline test	6 months
Secondary	Absence of VA episodes	ICD interrogation	6 months
Secondary	Absence of VA episodes	ICD interrogation and ajmaline test	12 months
Secondary	Absence of Br Pattern at ajmaline test	Normalization of 12-lead ECG recording and echo parameters at baseline and after ajmaline test	12 months
Secondary	Absence of Br Pattern at ajmaline test	Normalization of 12-lead ECG recording at baseline and after ajmaline test	18 months
Secondary	Absence of VA episodes	ICD interrogation	24 months
Secondary	Absence of Br ECG pattern after ajmaline test	Normalization of 12-lead ECG recording at baseline and after ajmaline test	24 months
Secondary	Absence of VA episodes at EP study	ICD interrogation	36 months
Secondary	Absence of Br Pattern at ajmaline test	Normalization of 12-lead ECG recording at baseline and after ajmaline test	36 months
Secondary	Absence of Br Pattern at ajmaline test	Normalization of 12-lead ECG recording at baseline and after ajmaline test	48 months
Secondary	Absence of VA episodes at EP study	ICD interrogation	48 months up to 120 months