NCT04755582

SMARTHEART Validation Study

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 128 (estimated)
• Sponsor: University of Leicester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Cardiovascular Diseases

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-02-16
• Last updated: 2021-02-16

Locations

1 site across 1 country: United Kingdom