Cardiac Autonomic Denervation for Cardio-inhibitory Syncope
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- recurrence of syncope
研究概览
简要总结
Background: Autonomic system modification is an established therapeutic approach that has been increasingly used for the treatment of vagal-related symptomatic bradycardia, such as cardio-inhibitory vasovagal syncope1-12.
Although convincing results had been reported from small populations, a large randomized study providing robust evidence on the efficacy of this approach has not yet been performed.
Hypothesis: Cardiac autonomic system modification is effective for the treatment of vagal-related symptomatic bradycardia, and is associated better clinical results as compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
all patients will go for intervention, however they will not know which group they were randomized to
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 70 years old.
- •Cardio-inhibitory response (VASIS 2A or 2B) during tilt test, or after carotid sinus massage.
- •Patients with bradycardia mediated by vagal hypertonia documented on 24-hour Holter monitoring and a clear relationship with symptoms.
排除标准
- •Ages under 18 and over 70
- •Presence of structural heart disease documented by echocardiography.
- •Hypothyroidism and hyperthyroidism, drug effects, obstructive sleep apnea and other causes of secondary bradycardia.
- •Anatomical disease of the conduction system.
结局指标
主要结局
recurrence of syncope
时间窗: 24 months
To compare the recurrence of syncope or pre-syncope and a negative tilt test with the different techniques of electrophysiological procedures currently used.
次要结局
- electrocardiographic and electrophysiological parameters(24 months)
研究者
Mauricio Ibrahim Scanavacca
Director of arrhythmia and electrophysiology Unit
University of Sao Paulo General Hospital