Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04755582
Status:
UNKNOWN
Last Update Posted:
2021-02-16
First Post:
2021-02-05
Brief Title:
SMARTHEART Validation Study
Sponsor:
University of Leicester
Organization:
University of Leicester
Study Overview
Official Title:
SMARTHEART Validation Study A Study to Assess the Accuracy and Validate Novel Smartphone and Wearable ECG Devices in Cardiovascular Patients
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 tonedryness 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
Posture or position of the patient
Movement
Amount of hair on the ECG site
Skin condition tonedryness 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None