Ablation in Brugada Syndrome for Prevention of VF - A Randomized, Multi-center Study of Epicardial Ablation in Brugada Syndrome Patients to Prevent Arrhythmia Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Freedom of Ventricular Fibrillation/Tachycardia Recurrences
研究概览
简要总结
This trial aims to develop evidence based curative treatment with optimal net benefit for patients with Brugada syndrome.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Freedom of Ventricular Fibrillation/Tachycardia Recurrences
时间窗: 3 year followup
Survival from ventricular fibrillation of shocked ventricular arrhythmias causing ICD discharge
次要结局
- Freedom without drug(3 years)
研究者
Koonlawee Nademanee, MD
Principal Investigator
Pacific Rim Electrophysiology Research Institute