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临床试验/NCT04138797
NCT04138797已完成不适用

Evaluation of Non-invasive Measurement of Electrophysiological "HV" Interval Using a High-density and High-fidelity Signal Averaging ECG Device

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年10月7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
入组人数
50
试验地点
2
主要终点
Measurement of HV interval correlation by graphical representation

研究概览

简要总结

His-Ventricle (HV) measurement is only obtained invasively using transvenous catheters. This kind of procedure is routinely performed but some risks of complication exist. HV interval prolongation is correlated with increased risk of occurrence of complete atrioventricular block which could lead to syncope or cardiac sudden death. A new non invasive, high density and high fidelity system (BioSemi, BioSemi B.V., Amsterdam, Netherlands) can theorically collect such electrophysiological signal using a signal averaging acquisition method. We want to assess the possibility of non invasive HV interval measurement using this new device.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • Patients admitted at Bordeaux University Hospital for electrophysiological study with HV measurement.

排除标准

  • Patients under 18 years old,
  • Pregnant or breastfeeding women.

结局指标

主要结局

Measurement of HV interval correlation by graphical representation

时间窗: Day 0

The correlation of the HV interval obtained using the 2 different methods, is measured by a graphical representation of Bland and Altman

Measurement of HV interval correlation by the intra-class correlation coefficient

时间窗: Day 0

The correlation of the HV interval obtained using the 2 different methods, is measured by a correlation coefficient

次要结局

未报告次要终点

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (2)

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