Clinical Trial: Ablation in Brugada Syndrome for the Prevention of VF

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Ablation in Brugada Syndrome for Prevention of VF - A Randomized, Multi-center Study of Epicardial Ablation in Brugada Syndrome Patients to Pr

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

Detailed Summary: 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.
Sponsor: Pacific Rim Electrophysiology Research Institute

Current Primary Outcome: Freedom of Ventricular Fibrillation/Tachycardia Recurrences [ Time Frame: 3 year followup ]

Survival from ventricular fibrillation of shocked ventricular arrhythmias causing ICD discharge


Original Primary Outcome: Same as current

Current Secondary Outcome: Freedom without drug [ Time Frame: 3 years ]

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


Original Secondary Outcome: Same as current

Information By: Pacific Rim Electrophysiology Research Institute

Dates:
Date Received: February 18, 2016
Date Started: July 2016
Date Completion: July 2021
Last Updated: September 26, 2016
Last Verified: September 2016