SMARTHEART Validation Study

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04755582
• Other study ID #: 0693
• Status: Not yet recruiting
• Start date: July 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2021
• Source: University of Leicester
• Contact: Zakariyya Vali
• Phone: 01162502366
• Email: z.vali[@]le.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 128
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Locations

Country	Name	City	State
United Kingdom	Glenfield Hospital, University Hospitals of Leicester NHS Trust	Leicester	Leicestershire

Sponsors (1)

Lead Sponsor	Collaborator
University of Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Assessing the effects on the ECG of: • Movement	Assessment of changes to the ECG signal due to movement of the patient	2 hours
Secondary	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
Secondary	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
Secondary	Ability to detect a paced rhythm accurately.	Assessment of ability of ECG device to detect paced ECG complexes or pacing spikes	2 hours
Secondary	A qualitative assessment of ECG devices, including the amount of artefact in the signal and ease of use of the device.		12 months