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Completed

NCT Number: NCT04420078

Brugada Ablation of VF Substrate Ongoing MultiCenter Registry

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pacific Rim Electrophysiology Research Institute, Chulalongkorn University

Bangkok, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Catheter ablation

Procedure

Ventricular fibrillation substrate

Primary outcomes

  1. Death

    Time frame: 3 years

    Expiration, unrelated to procedure

  2. ICD Therapy for VT/VF

    Time frame: 3 years

    Electrical therapy delivered through device for termination of VF episodes

Secondary outcomes

  1. Inappropriate ICD Therapy

    Time frame: 3 years

    Caused by lead sensing or programming errors

  2. Normalization of Brugada ECG pattern

    Time frame: 3 years

    ECG pattern is normal sinus rhythm after catheter ablation

Sponsors and collaborators

Lead sponsor

Pacific Rim Electrophysiology Research Institute

Other

Collaborators

  • Indiana University
  • Ogaki Municipal Hospital
  • Taipei Veterans General Hospital, Taiwan
  • University Hospital, Bordeaux
  • University of Amsterdam
  • University of London
  • University of Tsukuba
  • Zhejiang University

Registry information

Acronym: BRAVO

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Jun 9, 2020
Registry last updated
Nov 21, 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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