Evaluation of Novel Torque Device During Electrophysiology Study Procedure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Difference in Sensing of Chamber Amplitude (mV)
研究概览
简要总结
This study will evaluate the safety and efficacy of a novel catheter torque device after the completion of a clinically-indicated electrophysiology study and/or ablation procedure in a pediatric patient. All electrophysiology studies and/or ablation procedures will be performed at the discretion of their primary cardiologist and will not be affected by this study protocol. The study protocol will commence once the attending electrophysiologist has completed all necessary intervention and testing and no further evaluation is required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patient (≤21 years of age)
- •Undergoing clinically-indicated electrophysiology study and/or ablation procedure
排除标准
- •Adult patient (>21 years)
研究组 & 干预措施
Torque Device
After the completion of the electrophysiology study and/or ablation procedure, the catheters remain in the intra-cardiac locations. While in place, measurements will be obtained from each catheter. Once the baseline measurements have been obtained, the Peritorq device will be placed onto each relevant catheter. Once secured, all measurements will be repeated with each catheter at the identical location. After measurements have been obtained, the operator will perform minor catheter movements to note subjective maneuverability and stability of the catheter with the torque device in place
干预措施: Peritorq (Device)
结局指标
主要结局
Difference in Sensing of Chamber Amplitude (mV)
时间窗: 15 minutes
Obtained from catheter at baseline and after Peritorq device placed
Difference in Impedance
时间窗: 15 minutes
Obtained from catheter at baseline and after Peritorq device placed
Difference in Capture Threshold of Atrium and Ventricle (mA)
时间窗: 15 minutes
Obtained from catheter at baseline and after Peritorq device placed
次要结局
未报告次要终点
