NCT02704416

Ablation in Brugada Syndrome for the Prevention of VF

Ablation in Brugada Syndrome for Prevention of VF - A Randomized, Multi-center Study of Epicardial Ablation in Brugada Syndrome Patients to Prevent Arrhythmia Recurrence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Pacific Rim Electrophysiology Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brugada Syndrome

Interventions

Type	Name	Description
PROCEDURE	Catheter Ablation	catheter ablation of fragmented signal in the right ventricular outflow tract

Timeline

• Start date: 2016-07-01
• Primary completion: 2024-11-13
• Completion: 2024-11-13
• First posted: 2016-03-10
• Last updated: 2024-11-21

Locations

6 sites across 2 countries: Netherlands, Thailand