跳至主要内容
临床试验/NCT07291570
NCT07291570进行中(未招募)不适用

Precision Detection and Prediction of Atrial Arrhythmias Using Artificial Intelligence and Consumer Wearable Devices (REMOTE-AF2)

Royal Brompton & Harefield NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年1月13日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
2
主要终点
To evaluate the accuracy of an AI algorithm based on PPG-derived metrics in predicting and detecting AF against intermittent rhythm monitoring.

研究概览

简要总结

Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia affecting over one million people in the UK. It is associated with increased cardiovascular morbidity and mortality and costs the NHS between £1.4 billion and 2.5 billion annually. Current methods to detect AF include opportunistic pulse palpation, single time point 12-lead electrocardiograms (ECGs), ambulatory Holter monitoring, and implantable loop recorders (ILRs). The more widely used intermittent monitoring methods, such as ECGs and Holter monitoring, are limited in terms of duration and have lower detection yields of atrial arrhythmias. At the other end of the spectrum, the ILR can give continuous and accurate arrhythmia detection but is invasive and requires specialist expertise to implant, monitor, and analyse.

In recent years, the use of wearable mobile health (mHealth) devices has emerged as a direct-to-consumer option for monitoring parameters such as heart rate and activity levels. From a clinical perspective they potentially offer a less invasive and cost-effective investigative approach, with remote monitoring solutions to possibly predict and detect AF. This technology has significant potential in terms of passive, non-invasive and continuous monitoring to aid the early diagnosis and management of AF.

The original REMOTE-AF study (NCT05037136) developed novel methodology to detect AF using PPG-dervived data from a wearable. This study will further enhance this foundational work by recruiting patients to develop a AI-enabled, multi-parametric algorithm using PPG-derived data to detect AF.

研究设计

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

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

  • Adults aged 18 and above with a confirmed diagnosis of paroxysmal AF or those who have undergone treatment for paroxysmal, or persistent AF and had sinus rhythm restored.
  • Capability to provide informed consent, coupled with self-reported sufficiency of digital literacy.
  • Regular access to a Wi-Fi connection (at least weekly).
  • Own a smartphone (released after 2017).

排除标准

  • Individuals with permanent or persistent AF that remains uncontrolled despite receiving treatment.
  • Conditions or disabilities that preclude adherence to study instructions or proper use of the devices.
  • A known severe allergy to any of the materials in the wearable or ECG device poses a risk to participant safety.

结局指标

主要结局

To evaluate the accuracy of an AI algorithm based on PPG-derived metrics in predicting and detecting AF against intermittent rhythm monitoring.

时间窗: 6 Months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验