Ablation in Brugada Syndrome for the Prevention of VF

Not Applicable

Completed

• Conditions: Brugada Syndrome
• Interventions: Procedure: Catheter Ablation

• Registration Number: NCT02704416
• Lead Sponsor: Pacific Rim Electrophysiology Research Institute

Brief Summary

This trial aims to develop evidence based curative treatment with optimal net benefit for patients with Brugada syndrome.

Detailed Description

This trial aims to develop evidence based curative treatment with optimal net benefit for patients with Brugada syndrome. Since a recent non-randomized pilot study and scarce case reports documented potential clinical benefit of epicardial ablation of fragmented electrograms in the region of the right ventricular outflow tract, patients in this trial will be randomized to continued implanted cardioverter defibrillator therapy (control arm) or ablation of areas of fragmented electrograms in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy (intervention arm). A projected 92 patients in each group will be studied.

Study Timeline

• Study First Submitted: 2016-02-18
• Study First Submitted QC: 2016-03-04
• Study First Posted: 2016-03-10
• Study Start: 2016-07
• Status Verified: 2024-11
• Primary Completion: 2024-11-13
• Study Completion: 2024-11-13
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• The diagnosis of Brugada syndrome is based on 2013 HRS/EHRA/APHRS Consensus document criteria
• Diagnosed symptomatic BrS with an implanted ICD within the last 5 years
• Diagnosed symptomatic BrS with an implanted ICD longer than 5 years but has at least 1 appropriate shock within the last 5 years
• The patient is legally competent, willing and able to undergo the study and signed the informed consent
• The patient is willing and able to adhere to the follow-up visit protocol

Exclusion Criteria

• A patient who does not meet inclusion criteria
• A patient who has had a previous epicardial ablation
• A patient who is pregnant (which would exclude an ablation procedure)
• A patient with a co-morbid condition that possesses undue risk of general anesthesia or epicardial ablation
• A patient who has a history of radiation therapy on the thorax

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Catheter Ablation	ablation of areas of fragmented signal in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy
Single Cross Over Arm	Catheter Ablation	these patients were initially assigned to the control arm of the study. When these patients met the primary outcome of the study it is allowed for these patients to be included in the intervention arm and/or to start quinidine

Primary Outcome Measures

Name	Time	Method
Freedom of Ventricular Fibrillation/Tachycardia Recurrences	3 year followup	Survival from ventricular fibrillation of shocked ventricular arrhythmias causing ICD discharge

Secondary Outcome Measures

Name	Time	Method
Freedom without drug	3 years	Freedom of shocked ventricular arrhythmias without the use of anti-arrhythmic drugs during 3 years of follow-up

Trial Locations

Locations (6)

Academic Medical Center, University of Amsterdam; 🇳🇱 Amsterdam, Netherlands

Bhumipol Adulyadej Hospital, Royal Thai Air Force; 🇹🇭 Bangkok, Thailand

Chulalongkorn University; 🇹🇭 Bangkok, Thailand

Pacific Rim Electrophysiology Research Institute Data Coordinating Center; 🇹🇭 Bangkok, Thailand

Ramathibodi Hospital; 🇹🇭 Bangkok, Thailand

Chiang Mai University; 🇹🇭 Chiang Mai, Thailand