NCT06887387招募中不适用
Application of Wearable Devices for Remote QT Interval Monitoring and Symptom Investigation for Patients With Long QT Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1. Determine the accuracy of repeated QT interval measurements using Fitbit-derived ECGs in patients with Long QT syndrome compared with the current standard (12-lead ECG and ambulatory monitors)
研究概览
简要总结
The main research question of this study is whether wearable devices have utility in monitoring patients with Long QT syndrome.
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
- 否
入选标准
- •Clinical diagnosis of Long QT Syndrome
- •Aged 18 years or over
- •Phone with iOS version 15 or Android OS 9.0 or higher
- •Able and willing to provide informed consent
排除标准
- •Unwilling or unable to give consent
- •Ventricular pacing at recruitment
- •Bundle branch block or pre-excitation at baseline
结局指标
主要结局
1. Determine the accuracy of repeated QT interval measurements using Fitbit-derived ECGs in patients with Long QT syndrome compared with the current standard (12-lead ECG and ambulatory monitors)
时间窗: From enrollment to 3 months
2. Establish intra-patient QT variability from weekly Fitbit-ECGs and frequency of measurements over 500ms.
时间窗: From enrollment to 3 months
次要结局
- 1. Establish the utility of wearable devices for determining symptom aetiology in LQTS.(From enrollment to 3 months)
- 2. Develop pipelines for the analysis of ECG data collected remotely including use of in-house QT automated algorithms for future machine learning applications.(From enrollment to 3 months)
研究者
研究点 (1)
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