Brugada Ablation of VF Substrate Ongoing MultiCenter Registry

NCT04420078 | Completed

• 1 other identifier: BRAVO Registry
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brugada Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Inappropriate ICD Therapy

  3 years

• Normalization of Brugada ECG pattern

  3 years

Study Arms (1)

CA BrS

Symptomatic BrS patients who underwent catheter ablation of the BrS/VF substrate

Procedure: Catheter Ablation

Interventions

Catheter Ablation PROCEDURE

Ventricular fibrillation substrate

CA BrS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Symptomatic Brugada Syndrome patients who had undergone catheter ablation of the arrhythmogenic substrates.

You may not qualify if:

• Patients who will not commit to regular follow up.

Sponsors & Collaborators

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

Study Sites (1)

Pacific Rim Electrophysiology Research Institute, Chulalongkorn University

Bangkok, Thailand

Location

Related Publications (1)

• Nademanee K, Chung FP, Sacher F, Nogami A, Nakagawa H, Jiang C, Hocini M, Behr E, Veerakul G, Jan Smit J, Wilde AAM, Chen SA, Yamashiro K, Sakamoto Y, Morishima I, Das MK, Khongphatthanayothin A, Vardhanabhuti S, Haissaguerre M. Long-Term Outcomes of Brugada Substrate Ablation: A Report from BRAVO (Brugada Ablation of VF Substrate Ongoing Multicenter Registry). Circulation. 2023 May 23;147(21):1568-1578. doi: 10.1161/CIRCULATIONAHA.122.063367. Epub 2023 Mar 24.

  PMID: 36960730 DERIVED

MeSH Terms

Conditions

Brugada Syndrome

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: June 9, 2020
• Study Start: July 1, 2017
• Primary Completion: February 28, 2022
• Study Completion: December 1, 2023
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)