NCT04755582Unknown不适用
SMARTHEART Validation Study. A Study to Assess the Accuracy and Validate Novel Smartphone and Wearable ECG Devices in Cardiovascular Patients
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Accuracy of smartphone or wearable ECG devices compared to gold standard ECG devices
研究概览
简要总结
To compare the accuracy of novel smartphone or wearable ECG devices to a gold standard ECG in patients with normal and abnormal ECGs.
详细描述
Assess the effect of the following on the accuracy of the recorded ECG compared to a gold standard ECG:
- Posture or position of the patient
- Movement
- Amount of hair on the ECG site
- Skin condition (tone/dryness) Ability to detect a paced rhythm accurately A qualitative assessment of ECG devices, including the amount of artefact in the signal and ease of use of the device
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Participant is willing and able to give informed consent for participation in the study.
- •Must have an adequate understanding of written and spoken English
- •Able (in the Investigators opinion) and willing to comply with study requirements.
- •Must be over 18 years of age
- •Must be deemed clinically stable by their direct care team.
排除标准
- •Subjects who do not have an adequate understanding of written and spoken English
- •Patients who are medically unstable, as defined by the patient's direct care team.
- •Patients who are unable to give informed consent
- •Patients who are deemed clinically unstable by their direct care team
结局指标
主要结局
Accuracy of smartphone or wearable ECG devices compared to gold standard ECG devices
时间窗: 2 hours
To compare the accuracy of novel smartphone or wearable ECG devices to a gold standard ECG in patients with normal and abnormal ECGs.
次要结局
- Assessing the effects on the ECG of: - Posture or position of the patient(2 hours)
- Assessing the effects on the ECG of: • Skin condition (tone/dryness)(12 months)
- Ability to detect a paced rhythm accurately.(2 hours)
- Assessing the effects on the ECG of: • Movement(2 hours)
- Assessing the effects on the ECG of: • Amount of hair on the ECG site(12 months)
- A qualitative assessment of ECG devices, including the amount of artefact in the signal and ease of use of the device.(12 months)
研究者
研究点 (1)
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