Comparison of Axillary Vein Puncture With Subclavian Vein Puncture in Pacemaker Implantation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Success rate of vein puncture
研究概览
简要总结
The intrathoracic subclavian venous technique for pacemaker implantation may be associated with serious complications. Axillary vein puncture tends to reduce lead implantation complications such as pneumothorax and lead crush, but clinical adoption is not widely acknowledged, especially in China, although this approach has been proposed for 20 years. The major concern is the learning curve for axillary vein puncture and its success rate. The investigators try to prove that the success rate of axillary vein puncture is non-inferior to subclavian vein puncture, hence to promote the clinical application of axillary vein puncture to reduce pacemaker implantation complications.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with indication of pacemaker or ICD implantation
- •Personally signed and dated informed consent document
排除标准
- •Accompanied with malignant disease or other disease, which cause life expectancy < 1 year.
- •Anatomical variation of axillary vein or subclavian vein, unable to puncture.
- •Poor compliance for follow-up.
- •Patients with any condition which, in the investigator's judgment, not suitable for enrollment.
结局指标
主要结局
Success rate of vein puncture
时间窗: 1 Day
次要结局
- Duration of pacemaker implantation(1 Day)
- Mechanical complication of electrode lead (combined endpoints of hemothorax, pneumothorax, air embolism, inadvertent arterial puncture, hematoma, fracture of electrode lead, nerve injury and subclavian crush syndrome)(6 months)
研究者
Xianlun Li
Deputy Director, Department of Cardiology
China-Japan Friendship Hospital