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临床试验/NCT04691245
NCT04691245Unknown不适用

Three Dimensional Ultrasound Guided Femoral Access for Transcatheter Aortic Valve Implantation

Catharina Ziekenhuis Eindhoven2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2021年2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
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

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

发起方
Catharina Ziekenhuis Eindhoven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Harm Scholten

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Catharina Ziekenhuis Eindhoven

研究点 (2)

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