Brugada Ablation of VF Substrate Ongoing MultiCenter Registry

Brugada Syndrome Clinical Trial

— BRAVO  

Official title:

Brugada Ablation of VF Substrate Ongoing MultiCenter Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04420078
• Other study ID #: BRAVO Registry
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: May 1, 2022

Study information

• Verified date: March 2023
• Source: Pacific Rim Electrophysiology Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: May 1, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brugada Syndrome

Intervention

Procedure:
• Catheter Ablation
Ventricular fibrillation substrate

Locations

Country	Name	City	State
Thailand	Pacific Rim Electrophysiology Research Institute, Chulalongkorn University	Bangkok

Sponsors (9)

Lead Sponsor	Collaborator
Pacific Rim Electrophysiology Research Institute	Indiana University, Ogaki Municipal Hospital, Taipei Veterans General Hospital, Taiwan, University Hospital, Bordeaux, University of Amsterdam, University of London, University of Tsukuba, Zhejiang University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	Expiration, unrelated to procedure	3 years
Primary	ICD Therapy for VT/VF	Electrical therapy delivered through device for termination of VF episodes	3 years
Secondary	Inappropriate ICD Therapy	Caused by lead sensing or programming errors	3 years
Secondary	Normalization of Brugada ECG pattern	ECG pattern is normal sinus rhythm after catheter ablation	3 years