Assessment of the Durability and Clinical Effectiveness of Parasympathetic Denervation Following Cardioneuroablation Using Physiological Indices of Heart Rate Reactivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in degree of parasympathetic denervation (%)
研究概览
简要总结
Cardioneuroablation is a novel treatment option for reflex-mediated syncope. It involves thermal destruction of neural tissue in the close proximity of heart using catheter introduced to the heart through vein in the groin. Effectiveness of the procedure is satisfactory, however, in some cases there is a possibility of the re-growth of previously ablated tissue. We aim to investigate whether this process could be traced by measurement of various physiological parameters related to heart rate reactivity. Additionally we intend to reveal whether changes in those parameters over time could influence clinical effeciveness of the procedure.
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
- •signed informed consent
- •sinus rhythm
- •clinical indications for cardioneuroablation for the treatment of vagally-mediated syncope
排除标准
- •pregnancy
- •known atropine hypersensitivity
结局指标
主要结局
Change in degree of parasympathetic denervation (%)
时间窗: 12 months
次要结局
- Change in heart rate (beats/min)(12 months)
- Change in heart rate variability (ms)(12 months)
- Change in cardiac barosensitivity (ms/mmHg)(12 months)
- Change in hypoxic heart rate response (beats/min SpO2)(12 months)
- Time to recurrence of syncopal event (days(12 months)
研究者
Piotr Niewinski, MD
MD, PhD
Wroclaw Medical University