Multi-center, Randomized, Controlled Trial to Compare Feasibility, Safety and Efficacy of Zero-Fluoroscopic Navigation With Conventional Fluoroscopic Navigation for Single-chamber Pacemaker Implantation
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Success rate
研究概览
简要总结
This study is intended to compare the feasibility, safety and efficacy of Ensite-NavX zero-fluoroscopic navigation system to conventional fluoroscopic X-ray approach as to performing single-chamber pacemaker implantation.
详细描述
Permanent pacemaker is a well-established treatment to treat patients with a wide range of heart rhythm disturbances.
Fluoroscopy is the imaging modality routinely used for cardiac device implantation and electrophysiological procedures.Due to the rising concern regarding the harmful effects of radiation exposure to both the patients and operation staffs, novel 3D mapping systems have been developed and implemented in electrophysiological procedure for the navigation of catheters inside the heart chambers.
Ensite NavX system can be used for cardiac imaging as a reliable and safe zero-fluoroscopy approach for implantation of single- or dual-chamber permanent pacemaker in patients. Our method offered a choice for some special population of patient in whom radiation exposure need to be avoided or in the extreme circumstances when the X-ray machine is out-of-order.
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
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sick Sinus Syndrome
- •complete Atrioventricular Block
- •high degree second Degree Atrioventricular Block
- •Bradycardia
排除标准
- •pacemaker replacement
- •severe structural l cardiac malformations
- •severe cardiac enlargement
- •venous malformations
研究组 & 干预措施
Zero-fluoroscopy implantation
Pacemaker implantation performed for all patients in this group with zero-fluoroscopy 3D navigation.
干预措施: zero-fluoroscopy 3D navigation (Procedure)
Conventional fluoroscopy implantation
Pacemaker implantation performed for all patients with conventional x-ray navigation.
干预措施: conventional x-ray navigation (Procedure)
结局指标
主要结局
Success rate
时间窗: 3 months
次要结局
- Total procedure time(during procedure)
- Complications(1 year)
- Fluoroscopy time(during procedure)