The Collection and Transmission of Electrocardiogram Using a Wearable Device

Arrhythmia Clinical Trial

Official title:

A Multi-center Clinical Trial to Explore the Status of Collection and Transmission of Electrocardiogram Using a Wearable Device

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05182684
• Other study ID #: VP-100-ECG
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2021
• Est. completion date: June 21, 2022

Study information

• Verified date: December 2021
• Source: Seoul National University Hospital
• Contact: SeungHwan Lee, Professor
• Phone: 82-02-2072-0694
• Email: hwan8495[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multi-center clinical trial to explore the status of collection and transmission of electrocardiogram using a wearable device

Description:

The collection and transmission of electrocardiograms to a central data server using a wearable device were evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 21, 2022
• Est. primary completion date: June 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmia
• Arrhythmias, Cardiac

Intervention

Device:
• Vital 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul National University Hospital Clinical Trial Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of data collected	Compare actual monitored and server collected times	6 hours
Secondary	The comparison of ventricular rate	Compare actual monitored and server collected ventricular rate	6 hours
Secondary	The comparison of abnormal events	Compare patient-reported adverse events with abnormal beats collected by a central server	6 hours