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Completed

NCT Number: NCT03764592

VF Mapping in Brugada and Early Repolarization Syndromes

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

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Key information

Conditions

Brugada Syndrome Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Early Repolarization Syndrome Genetic Diseases, Inborn Heart Diseases

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bumrungrad International Hospital, Bangkok, Thailand

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

radiofrequency ablation

Other

Symptomatic patients whose substrates were identified will undergo catheter ablation; asymptomatic patients will be followed without undergoing catheter ablation.

Primary outcomes

  1. VF death

    Time frame: 3 years

    ventricular fibrillation

Sponsors and collaborators

Lead sponsor

Pacific Rim Electrophysiology Research Institute

Other

Collaborators

  • University of Bordeaux

Registry information

Official study title

Mapping of Ventricular Fibrillation (VF) Substrates and VF Arrhythmogenic Sources/Reentrant Circuits in Patients With Brugada and Early Repolarization Syndromes

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Dec 5, 2018
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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