VF Mapping in Brugada and Early Repolarization Syndromes

Completed

• Conditions: Brugada Syndrome; Early Repolarization Syndrome
• Interventions: Other: radiofrequency ablation

• Registration Number: NCT03764592
• Lead Sponsor: Pacific Rim Electrophysiology Research Institute

Brief Summary

To determine the values and limitations of ECGI in guiding ablation and risk stratification in patients with BrS and Early Repolarization.

Detailed Description

The investigators will study symptomatic BrS and ERs syndrome (N=25) and asymptomatic patients (N=25) age between 16-70 years old to determine values and limitations of non-invasive mapping using electrocardiographic imaging (ECGI) in identifying VF substrates as target sites for catheter ablations in patients with Brugada (BrS) and Early repolarization syndromes (ERS) and also determine the mechanisms of VF in BrS and ERs syndromes.

Study Timeline

• Study Start: 2018-02-23
• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-05
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients presenting with the type1 BrS ECG or ER ECG signature pattern, with/without a sodium channel blocker. Patients with the following one of these symptoms or arrhythmias will be considered as symptomatic patients: 1) aborted cardiac arrest cases, 2) documented VF episodes, 3) agonal respiration during sleep with difficulty to arouse, 4) syncope of unknown origin, or 5) seizure suspected of arrhythmic origin.•

Exclusion Criteria

Patients who refuse informed consent and to participate to the best ability in the study.

Patients who have structural heart disease or concomitant medical illness.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VF BrS/ERS patients	radiofrequency ablation	Only patients that diagnosed with BrS or ERS based on ECG criteria

Primary Outcome Measures

Name	Time	Method
VF death	3 years	ventricular fibrillation

Trial Locations

Locations (2)

Bumrungrad International Hospital; 🇹🇭 Bangkok, Thailand

Pacific Rim Electrophysiology Research Institute Data Coordinating Center; 🇹🇭 Bangkok, Thailand