The Iliac Arterio-venous Fistula for Treatment of Neurally Mediated Syncope Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 主要终点
- Absence of loss of consciousness on tilt table testing
研究概览
简要总结
The purpose of the study is to investigate the efficacy of the ROX coupler in treating patients with tilt test proven Neurally mediated syncope.
详细描述
Neurally mediated syncope (NMS) is a debilitating condition, with no proven therapeutic measures. The ROX coupler is a device used to create an Iliac arterio-venous anastamosis which allows a shunt of 0.8 litres per minute. The haemodynamic changes following creation of an arterio-venous anastomosis at the iliac level leads to an increase in cardiac preload, reversing finding thought to induce NMS.
This a randomised controlled study to evaluate the effect of Iliac arterio-venous anastamosis in patients with neurally mediated syncope. The Head up tilt test is used as an objective measure to evaluate the effect of the arterio-venous anastamosis in patients with NMS. Participants with tilt test proven NMS will be eligible for the study ( if they satisfy all other eligibility criteria). Participants will be randomised to ROX coupler intervention or standard therapy. The primary outcome measure will be absence of loss consciousness on tilt table testing at 3 months post intervention.
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)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Absence of transient loss of consciousness associated with reflex bradycardia or hypotension on tilt testing at 3 months following randomised intervention
排除标准
- •Time to first episode of syncope after randomised intervention
- •Number of syncopal episodes in the first 3 months after randomised intervention.
- •Tilt table response at 6 months following randomised intervention i.e. 3 months after unblinding
- •Number of syncopal episodes at 6 months after intervention i.e. 3 months after unblinding
结局指标
主要结局
Absence of loss of consciousness on tilt table testing
时间窗: 3 months
Absence of loss of consciousness associated with reflex bradycardia or hypotension on head up tilt table testing at 3 months post intervention
次要结局
- Tilt table response at 6 months following randomised intervention i.e. 3 months after unblinding(6 months)
- Number of syncopal episodes at 6 months after intervention i.e. 3 months after unblinding(6 months)
- Time to first episode of syncope after randomised intervention(3 months)
- Number of syncopal episodes in the first 3 months after randomised intervention(3 months)
研究者
Neil Sulke
Dr
Eastbourne General Hospital