Rapid Ventricular Pacing in Surgical Treatment of Intracranial Aneurysms
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- modified Rankin scale
研究概览
简要总结
Treatment of complex unruptured intracranial aneurysms (UIA) remains challenging to date. Therefore, advanced techniques are required to achieve an optimal result in treating these patients safely. In this study, the safety and efficacy of rapid ventricular pacing (RVP) to facilitate microsurgical clip-reconstruction has been studied prospectively in a joined neurosurgical, anesthesiological and cardiological study.
详细描述
Treatment of complex unruptured intracranial aneurysms (UIA) remains challenging to date. Therefore, advanced techniques are required to achieve an optimal result in treating these patients safely. In this study, the safety and efficacy of rapid ventricular pacing (RVP) to facilitate microsurgical clip-reconstruction has been studied prospectively in a joined neurosurgical, anesthesiological and cardiological study. Patients with complex UIA were prospectively enrolled and the safety and efficacy of RVP were evaluated recording cardiovascular events and outcome of the patients as well as the amount of aneurysm occlusion after the surgical clip-reconstruction 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
- 是
入选标准
- •complex UIA intended to be treated by microsurgical clip-reconstruction
- •application of RVP intra-operatively
排除标准
- •structural heart disease or conductance abnormalities
研究组 & 干预措施
RVP
干预措施: Rapid Ventricular Pacing (Procedure)
结局指标
主要结局
modified Rankin scale
时间窗: 6 months
次要结局
- safety of pacing catheter(intraoperatively upt o 24 hours after operation)
- Cardiovascular events(intraoperatively upt o 24 hours after operation)
- Efficacy of flow reduction and improvement of clip application(intraoperatively)
- occlusion rate of aneurysm(1 week after operation)
研究者
Juergen Konczalla
MD
University Clinic Frankfurt