Brugada Ablation of VF Substrate Ongoing MultiCenter Registry (BRAVO)

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.

Study Overview

• Status: Completed
• Conditions: Brugada Syndrome
• Intervention / Treatment: Procedure: Catheter Ablation

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 Type: Observational
• Enrollment (Actual): 159

Contacts and Locations

• Study Contact: Name: Carla Drew, BS, MBA; Phone Number: 3104302613; Email: carla@pacificrimep.com

Study Locations

• Thailand
  • Bangkok, Thailand
    • Pacific Rim Electrophysiology Research Institute, Chulalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have positive Brugada ECG pattern and have underwent catheter ablation of VF substrates prior to enrollment.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CA BrS; Symptomatic BrS patients who underwent catheter ablation of the BrS/VF substrate	Procedure: Catheter Ablation; Ventricular fibrillation substrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Expiration, unrelated to procedure	3 years
ICD Therapy for VT/VF	Electrical therapy delivered through device for termination of VF episodes	3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pacific Rim Electrophysiology Research Institute
• Collaborators: University Hospital, Bordeaux; Taipei Veterans General Hospital, Taiwan; Indiana University; University of Amsterdam; University of London; Zhejiang University; University of Tsukuba; Ogaki Municipal Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Brugada Syndrome
• Other Study ID Numbers: BRAVO Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data published will be deindentified

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No