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临床试验/NCT02956343
NCT02956343已完成不适用

SmartWATCHes for Detection of Atrial Fibrillation

University Hospital, Basel, Switzerland2 个研究点 分布在 2 个国家目标入组 651 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
651
试验地点
2
主要终点
Correct detection of AF

研究概览

简要总结

In this trial the Preventives Heartbeats algorithm will be tested in two wearable devices for its specificity and sensitivity to distinguish between AF and SR.

详细描述

Introduction

Particularly in stroke prevention, the detection of atrial fibrillation is of pivotal importance. Recent studies have impressively confirmed the merits of long-term monitoring. Nevertheless, and despite very mature technology, the currently available methods like long-term ECG with conductive adhesive electrodes or implantable loop recorders are burdened with disadvantages in that they are inconvenient, costly and/or invasive. A predecessor study gave us the possibility to test an app that employs photoplethysmographic signals on a smartphone camera-similar to pulse oximetry technology-to distinguish between atrial fibrillation and sinus rhythm. That retrospective study achieved a sensitivity and specificity of 95% (Krivoshei et al., Europace 2016). The prospective follow-up study DETECT AF pro is currently being conducted in cooperation with Prof. Dörr in Greifswald, Germany.

Our research group has been involved with testing the app's quality in clinical settings before implementing it for use. This procedure differs markedly from the otherwise common practice of marketing qualitatively inferior "health apps" without any clinical testing. There is no app equipped with comparable technology worldwide. The WATCH AF study is the first study on sophisticated rhythm analysis using a smartwatch worldwide.

Study design

Prospective, blinded, multicenter study.

研究设计

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects of legal age,
  • patients with either sinus rhythm (Group SR) or atrial fibrillation (Group AF)
  • signed informed consent form

排除标准

  • Legally incompetent persons

结局指标

主要结局

Correct detection of AF

时间窗: 5 minutes

Sensitivity and specificity of the Preventicus Heartbeats App to distinguish between AF and SR

次要结局

  • Differences in correct detection of AF between Smartwatch and Wristband(5 minutes)
  • Reduced sensitivity and specificity in patients with >2% premature beats(5 minutes)

研究者

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

研究点 (2)

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