NCT03860090Unknown不适用
Prospective Randomized Comparison of Efficacy and Safety in Pacemaker and Defibrillator Implantation Via Cephalic Versus Axillary Vein Access. The CEPHAX Study.
Castilla-La Mancha Health Service2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2017年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Implant Success
研究概览
简要总结
This clinical trial evaluates the efficacy and safety of axillary versus cephalic venous access in the pacemakers and defibrillators implantation.
Half of participants will receive the implant via fluoroscopy guided axillary venous access and the other half will receive the implant via improved cephalic venous access.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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 a endovenous pacemaker or defibrillator indication.
排除标准
- •Pre-existing ipsilateral pacing electrode.
- •Previous ipsilateral lymphadenectomy.
- •Indication of cardiac resynchronization therapy.
结局指标
主要结局
Implant Success
时间窗: 30 days
Success of the implant through the assigned access vein
Implant Complications
时间窗: 30 days
All implant related complications
次要结局
- Lead Complications(From date of implant until the date of first documented, assessed up to 48 months)
- Pneumothorax(30 days)
- Bleeding(30 days)
- Upper limb thrombosis(From date of implant until the date of first documented, assessed up to 48 months)
研究者
研究点 (2)
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