Epicardial Ablation in 500 Consecutive Brugada Syndrome Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- VT/VF inducibility
研究概览
简要总结
This study represents an extension of a previous study (NCT02641431) on the acute and long-term benefit of epicardial ablation on elimination of both BrS-ECG pattern and VT/VF inducibility in 500 consecutive BrS patients.
详细描述
According to previous protocol (NCT02641431), 300 additional consecutive selected patients having an ICD implantation will be enrolled up to a total of 500 BrS patients. Echocardiography with cardiac deformation analysis, three-dimensional color-coded voltage, activation and duration electroanatomical maps before and after ajmaline (1mg/kg in 5 minutes) wiil determine the site and the size of the arrhythmogenic substrate as characterized by abnormally prolonged fragmented ventricular potentials and potential wall motion abnormalities. Primary endpoint will be identification and elimination of this electrophysiological substrate by RF applications leading to ECG pattern normalization and VT/VF non-inducibility before and after ajmaline. Patients will be followed up to 10 years after ablation by sequential 12-lead ECG and Holter recording, Echocardiography, ICD interrogation, VT/VF inducibility patterns before and after ajmaline test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Symptomatic BrS patients with typical BrS-related symptoms (cardiac arrest or syncope) or without typical BrS-related symptoms (dizziness, palpitations, presyncope, dyspnea) ICD implantation, spontaneous or ajmaline-induced type 1 Br pattern.
排除标准
- •Age < 18 years, prior epicardial ablation, pregnancy, co-morbidities.
结局指标
主要结局
VT/VF inducibility
时间窗: immediately after mapping and ablation
Programmed stimulation was achieved at twice the diastolic threshold and randomly performed at RV apex and RV outflow tract using up to 3 drive cycle lengths (from 600 to 350ms) and up to three extrastimuli (S2-S4) delivered from the apex and outflow tract of the right ventricle.
Absence of VT/VF
时间窗: 1,3,6,12,18,24,36,48,60,72,84,96,108,120 months after ablation
Absence of VT/VF by ICD interrogation
Type 1 BrS-ECG pattern elimination by epicardial ablation before and after ajmaline test.
时间窗: 1 day after ablation
Normalization of ECG pattern after elimination by radio-frequency ablation of all abnormal epicardial potentials
次要结局
- Absence of Br Pattern and RV mechanical abnormalities using echo and cardiac deformation analysis before and after ajmaline test(3 months)
- Absence of VA episodes at EP study(48 months up to 120 months)
- Absence of Br ECG pattern after ajmaline test(24 months)
- Absence of Br Pattern at ajmaline test(48 months)
- Absence of VA episodes(24 months)
研究者
Carlo Pappone
Department Director, MD
IRCCS Policlinico S. Donato