NCT03106701

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

Epicardial Ablation in 500 Consecutive Brugada Syndrome Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: IRCCS Policlinico S. Donato · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ECG Brugada Pattern

Interventions

Type	Name	Description
PROCEDURE	Ablation	Epicardial Radiofrequency ablation

Timeline

• Start date: 2017-03-14
• Primary completion: 2023-09-28
• Completion: 2023-12-30
• First posted: 2017-04-10
• Last updated: 2023-10-02

Locations

1 site across 1 country: Italy