SMARTHEART Validation Study

Study Overview
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Brief Summary
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To compare the accuracy of novel smartphone or wearable ECG devices to a gold standard ECG in patients with normal and abnormal ECGs.

Detailed Description
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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

Official Title
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SMARTHEART Validation Study. A Study to Assess the Accuracy and Validate Novel Smartphone and Wearable ECG Devices in Cardiovascular Patients

Conditions
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Cardiovascular Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of smartphone or wearable ECG devices compared to gold standard ECG devices | To compare the accuracy of novel smartphone or wearable ECG devices to a gold standard ECG in patients with normal and abnormal ECGs. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing the effects on the ECG of: - Posture or position of the patient | Assessment of changes to the ECG signal due to posture or position of the patient | 2 hours | 
| Assessing the effects on the ECG of: • Movement | Assessment of changes to the ECG signal due to movement of the patient | 2 hours | 
| Assessing the effects on the ECG of: • Amount of hair on the ECG site | Assessment of changes to the ECG signal due to amount of hair on the site of ECG electrode positions | 12 months | 
| Assessing the effects on the ECG of: • Skin condition (tone/dryness) | Assessment of changes to the ECG signal due to different skin conditions on the site of ECG electrode positions | 12 months | 
| Ability to detect a paced rhythm accurately. | Assessment of ability of ECG device to detect paced ECG complexes or pacing spikes | 2 hours | 
| A qualitative assessment of ECG devices, including the amount of artefact in the signal and ease of use of the device. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wearable ecg, electrocardiogram