Epicardial Ablation in Brugada Syndrome in the Prevention of Sudden Cardiac Death. A Randomized Prospective Follow-up Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Survival from any VA recurrence will be considered as primary endpoint
研究概览
简要总结
A total of 150 patients will be randomized to perform catheter ablation or not in a 2:1 fashion in selected patients with Brugada-related symptoms (Ablation+ICD arm 105 patients vs ICD only 45 patients).
详细描述
The main purpose of this trial is to develop evidence-based curative treatment with optimal net benefit for patients with Brugada syndrome. As recent non-randomized pilot studies and scarce case reports documented the potential benefit of epicardial ablation, patients in this trial will be randomized to epicardial catheter ablation of the regions exhibiting abnormally prolonged and fragmented electrograms in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy (ablation arm) or continued implanted cardioverter defibrillator therapy (control arm).
Survival from any ventricular arrhythmia (VA) recurrence will be considered as primary endpoint.
A projected 150 patients will be enrolled and randomized to receive ablation or not in a 2:1 fashion (Ablation+ICD arm 105 patients vs ICD only 45 patients).
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
- •Patients affected by Brugada Syndrome diagnosed according to 2013 HRS/EHRA/APHRS
- •Consensus document criteria
- •The patient received at least 1 appropriate ICD shock.
- •Documentation of any previous ventricular arrhythmia (VA) in the form of VT, non-sustained VT, non-sustained VF, RVOT PVC with a daily burden >10000;
- •Age ≥ 18;
- •Willingness to attend follow-up examinations;
- •Written informed consent for participation in the trial.
排除标准
- •A patient who does not meet inclusion criteria;
- •Pregnancy or breast-feeding (which would exclude an ablation procedure);
- •Contraindications to general anesthesia or epicardial ablation;
- •Life expectancy < 12 months
结局指标
主要结局
Survival from any VA recurrence will be considered as primary endpoint
时间窗: 2 years after ablation
NO ventricular arrhythmia recurrence
次要结局
未报告次要终点
研究者
Carlo Pappone
Chief of Arrhythmology Department
IRCCS Policlinico S. Donato