跳至主要内容
临床试验/NCT04928326
NCT04928326已完成不适用

Comparison of the InCardia Venous Pressure Diagnostic Technology CorWatch With Swan Ganz Catheter Measurements in the Cardiac Catheterization Laboratory and Cardiac Intensive Care Unit

InCardia Inc.1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
InCardia Inc.
入组人数
43
试验地点
1
主要终点
Agreement with right atrial pressure as measured by Swan Ganz catheter

研究概览

简要总结

This is an observational study to evaluate the agreement between the InCardia diagnostic technology CorWatch for the assessment of venous pressure in human subjects. This includes evaluation of InCardia technology in heart failure (HF) patients undergoing invasive right heart catheterization in a cardiac catheterization laboratory (cath lab) and in a cardiac intensive care unit (ICU).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
21 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with NYHA class II-IV heart failure irrespective of ejection fraction
  • Patient is able to give consent

排除标准

  • Severe tricuspid regurgitation
  • Mechanical ventilation
  • Patient is pregnant
  • Inability to access either of the patient's upper arms.

结局指标

主要结局

Agreement with right atrial pressure as measured by Swan Ganz catheter

时间窗: During the right heart catheterization procedure

Agreement between the CVP/RAP as assessed by the CorWatchTM method and the right arterial pressure (RAP) as measured by SG catheter

次要结局

未报告次要终点

研究者

发起方
InCardia Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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