Brugada Ablation of VF Substrate Ongoing MultiCenter Registry

Completed

• Conditions: Brugada Syndrome

• Registration Number: NCT04420078
• Lead Sponsor: Pacific Rim Electrophysiology Research Institute

Brief Summary

Current treatment of high-risk Brugada Syndrome (BrS) patients (pts) with recurrent VF is limited. Catheter ablation (CA) has been performed for BrS but a large study with long-term outcomes of CA in BrS ablation are lacking.

Detailed Description

Brugada syndrome (BrS) patients who undergo BRS substrate ablations from tertiary centers for catheter ablations of complex arrhythmias from three continents - Asia, Europe and North America - are registered in a common database. The investigators exclude patients who were lost to follow up in the outpatient clinic.

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-06-03
• Study First Posted: 2020-06-09
• Primary Completion: 2022-02-28
• Study Completion: 2023-12-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

• Symptomatic Brugada Syndrome patients who had undergone catheter ablation of the arrhythmogenic substrates.

Exclusion Criteria

• Patients who will not commit to regular follow up.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death	3 years	Expiration, unrelated to procedure
ICD Therapy for VT/VF	3 years	Electrical therapy delivered through device for termination of VF episodes

Secondary Outcome Measures

Name	Time	Method
Inappropriate ICD Therapy	3 years	Caused by lead sensing or programming errors
Normalization of Brugada ECG pattern	3 years	ECG pattern is normal sinus rhythm after catheter ablation

Trial Locations

Locations (1)

Pacific Rim Electrophysiology Research Institute, Chulalongkorn University; 🇹🇭 Bangkok, Thailand