Three Dimensional Ultrasound Guided Femoral Access for Transcatheter Aortic Valve Implantation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- first pass success
研究概览
简要总结
Rationale: Bleeding and vascular complications of the femoral artery still account for significant morbidity and mortality in transcatheter aortic valve implantation procedures. Although steadily declining over the past years through smaller diameter devices and use of ultrasound, major complications still occur in 3-4 % of patients. Femoral access is often obtained using 2D US guidance already. New 3D US probes can aid in increasing anatomical awareness. This can improve first pass success during procedures. Furthermore, for new closure devices, entering the artery at a straight angle at precisely 12 o'clock probably reduces complications. Therefore, the investigators hypothesize improved real time needle guidance using three dimensional ultrasound can decrease procedure related complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult age (>18 years)
- •Scheduled to undergo elective transcatheter aortic valve implantation with percutaneous access through the femoral artery
- •Written Informed consent
排除标准
- •Unable to obtain informed consent
- •Vascular access via alternative approach (radial/subclavian) or surgical cutdown
结局指标
主要结局
first pass success
时间窗: during procedure/surgery
successful entry in femoral artery within one skinbreak and without needle redirections
次要结局
- imaging time(during procedure/surgery)
- procedure time(during procedure/surgery)
- 12 o clock entry(during procedure/surgery)
- total number of punctures(during procedure/surgery)
- number of needle redirections(during procedure/surgery)
- operator satisfaction(during procedure/surgery)
- needle visualization(during procedure/surgery)
研究者
Harm Scholten
md
Catharina Ziekenhuis Eindhoven
