VF Mapping in Brugada and Early Repolarization Syndromes

November 15, 2023 updated by: Koonlawee Nademanee, MD, Pacific Rim Electrophysiology Research Institute

Mapping of Ventricular Fibrillation (VF) Substrates and VF Arrhythmogenic Sources/Reentrant Circuits in Patients With 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.

Study Overview

Status

Recruiting

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Bangkok, Thailand
        • Recruiting
        • Pacific Rim Electrophysiology Research Institute Data Coordinating Center
        • Contact:
        • Principal Investigator:
          • Koonlawee Nademanee, MD
      • Bangkok, Thailand
        • Recruiting
        • Bumrungrad International Hospital
        • Principal Investigator:
          • Koonlawee Nademanee, MD
        • Contact:
          • Koonlawee Nademanee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Brugada marker or early repolarization marker on ECG.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
VF BrS/ERS patients
Only patients that diagnosed with BrS or ERS based on ECG criteria
Symptomatic patients whose substrates were identified will undergo catheter ablation; asymptomatic patients will be followed without undergoing catheter ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VF death
Time Frame: 3 years
ventricular fibrillation
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Koonlawee Nademanee, MD, Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2018

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

December 3, 2018

First Submitted That Met QC Criteria

December 3, 2018

First Posted (Actual)

December 5, 2018

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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