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临床试验/NCT07442175
NCT07442175招募中不适用

Blood Pressure Monitor (TH-75) Atrial Fibrillation Detection Function Clinical Trial

Andon Health Co., Ltd1 个研究点 分布在 1 个国家目标入组 392 人开始时间: 2026年2月9日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
392
试验地点
1
主要终点
Accuracy of atrial fibrillation detection by the TH-75 blood pressure monitor, assessed against the prespecified acceptance criteria.

研究概览

简要总结

This study evaluates the accuracy of a blood pressure monitor in detecting atrial fibrillation by comparing its results with a standard diagnostic method.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • Atrial Fibrillation (AF):
  • Age ≥ 22 years;
  • Arm circumference between 22 cm and 42 cm;
  • Diagnosed with atrial fibrillation by a qualified medical institution.
  • Non-Atrial Fibrillation:
  • Age ≥ 22 years;
  • Arm circumference between 22 cm and 42 cm;
  • No prior diagnosis of atrial fibrillation.

排除标准

  • Pregnant women
  • Presence of an implanted cardiac pacemaker and/or defibrillator
  • Inability to cooperate with blood pressure measurement or ECG assessment
  • Any condition that, in the opinion of the investigator, makes the participant unsuitable for participation in this clinical study

研究组 & 干预措施

Subjects use Blood Pressure Monitor (TH-75) and ECG

结局指标

主要结局

Accuracy of atrial fibrillation detection by the TH-75 blood pressure monitor, assessed against the prespecified acceptance criteria.

时间窗: Baseline

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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