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

University of Leicester1 site in 1 country128 target enrollmentJuly 1, 2021

ConditionsCardiovascular Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cardiovascular Diseases
Sponsor: University of Leicester
Enrollment: 128
Locations: 1
Primary Endpoint: Accuracy of smartphone or wearable ECG devices compared to gold standard ECG devices
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

July 1, 2021

End Date

December 31, 2022

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of Leicester

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Accuracy of smartphone or wearable ECG devices compared to gold standard ECG devices

Time Frame: 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.

Secondary Outcomes

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)