The Collection and Transmission of Electrocardiogram Using a Wearable Device

Not Applicable

• Conditions: Arrhythmia
• Interventions: Device: Vital Patch(TriBell Lab)

• Registration Number: NCT05182684
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2021-10-25
• Study Start: 2021-10-26
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-21
• Last Update Submitted: 2021-12-21
• Study First Posted: 2022-01-10
• Last Update Posted: 2022-01-10
• Primary Completion: 2022-06-21
• Study Completion: 2022-06-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Vital Patch(TriBell Lab)	Electrocardiograms were measured by VP-100 for more than 6 hours and transmitted to a central server.

Primary Outcome Measures

Name	Time	Method
The proportion of data collected	6 hours	Compare actual monitored and server collected times

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Seoul National University Hospital Clinical Trial Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of