Prospective Randomized Comparison of Efficacy and Safety of Ultrasound-guided Axillary Vein Access Versus Cephalic Venous Cutdown for Implantation of Cardiac Electronic Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Success of venous access
研究概览
简要总结
Venous access is a fundamental step in lead insertion for endovenous cardiac implantable electronic devices (CIED). Cephalic vein cutdown is the most widely used technique in Europe. Ultrasound-guided axillary vein access is a promising alternative but there is a lack of clinical evidence supporting this technique.
The purpose of this study is to compare the efficacy and safety of ultrasound-guided axillary vein access versus cephalic venous cutdown for implantation of endovenous CIED.
Half of patients is implanted using an ultrasound-guided axillary vein puncture. The other half is implanted using a cephalic vein cutdown. After venous access is achieved, implantation procedure is identical in the two arms.
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
- •18 years or older
- •Indication for endovenous pacemaker or cardioverter-defibrillator (single or double room)
排除标准
- •History of previously implanted endocardial lead
- •Indication for cardiac resynchronization therapy
- •Impossibility of venous access
- •Unable/unwilling to provide informed consent
- •Pregnant or breastfeeding woman
- •Participating in another clinical study which can interfere with this study
结局指标
主要结局
Success of venous access
时间窗: Intervention time (day 0)
This outcome is measured by the operator during the intervention. It is the ability to successfully cannulate the vein and have all needed guidewire in the right atrium using the assigned venous access technique. The outcome is a binary value: success or failure.
次要结局
- X-Ray exposure(Intervention time (day 0))
- Cardiac implantable electronic device (CIED) related infection(Month 3)
- Procedure duration(Intervention time (day 0))
- Fluoroscopy time(Intervention time (day 0))
- Time to venous access(Intervention time (day 0))
- Complication(Intervention time (day 0))