跳至主要内容
临床试验/NCT04499807
NCT04499807终止不适用

Accuracy of Rhythm Detection and Managing Data Deluge by a Wearable Smart Watch for Cardiac Arrhythmias (The WATCH-RHYTHM Study)

Kansas City Heart Rhythm Research Foundation2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2021年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
16
试验地点
2
主要终点
AFib detection with heart rate data measured by Smart Watch

研究概览

简要总结

It is an attempt to see the reliability of the Wearable Smart Watch in identifying atrial fibrillation and other arrhythmias compared to the data detected from ILRs.

详细描述

The sensitivity, specificity, positive and negative predictive values for successful identification of normal sinus rhythm, atrial fibrillation and other rhythm disorders from the smart watch will compared to that of an ILR.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age over 18 years old
  • Patients who have an implantable loop recorder for heart rhythm monitoring purposes
  • Having IOS iphone device that can be integrated into Apple Watch
  • Willing to sign a consent form and participate in the study

排除标准

  • Hemodynamically unstable patients
  • Over 90 years of age
  • Presence of wrist tattoos
  • Presence of AV fistula on the wrist on which the wearable is worn. (If the contralateral wrist is unaffected, those patients can be included)
  • Presence of Implantable Cardiac Pacemaker and/or ICD
  • Patients with Parkinsons disease or tremors

结局指标

主要结局

AFib detection with heart rate data measured by Smart Watch

时间窗: 5 months

Heart rate data generated by Smart Watch is used to assess their rhythm as confirmed by the ILR done during the same time.

次要结局

未报告次要终点

研究者

发起方
Kansas City Heart Rhythm Research Foundation
申办方类型
Other
责任方
Sponsor

研究点 (2)

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