Arrhythmia
Conditions
Brief summary
A multi-center clinical trial to explore the status of collection and transmission of electrocardiogram using a wearable device
Detailed description
The collection and transmission of electrocardiograms to a central data server using a wearable device were evaluated.
Interventions
DEVICEVital Patch(TriBell Lab)
Electrocardiograms were recorded using VP-100 for more than six hours and transmitted to a central data server located in Seoul National University Hospital. The data on a central server was confirmed and evaluated.
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult male volunteers who can use an Android smartphone. * The subjects who voluntarily agree to participate and give written informed consent.
Exclusion criteria
* The subjects who have hypersensitivity to adhesives, such as medical bandages, or have clinically significant skin lesions. * The subjects who are judged to be inappropriate for the clinical trials to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of data collected | 6 hours | Compare actual monitored and server collected times |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The comparison of ventricular rate | 6 hours | Compare actual monitored and server collected ventricular rate |
| The comparison of abnormal events | 6 hours | Compare patient-reported adverse events with abnormal beats collected by a central server |
Countries
South Korea
Contacts
Primary ContactSeungHwan Lee, Professor
Outcome results
None listed