The Collection and Transmission of Electrocardiogram Using a Wearable Device

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05182684

Collaborator

(none)

Enrollment

Locations

Arm

7.8

Anticipated Duration (Months)

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Arrhythmia	Device: Vital Patch(TriBell Lab)	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 26, 2021

Anticipated Primary Completion Date :

Jun 21, 2022

Anticipated Study Completion Date :

Jun 21, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single arm Electrocardiograms were measured by VP-100 for more than 6 hours and transmitted to a central server.	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.

Arm

Intervention/Treatment

Experimental: Single arm

Electrocardiograms were measured by VP-100 for more than 6 hours and transmitted to a central server.

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.

Outcome Measures

Primary Outcome Measures

The proportion of data collected [6 hours]
Compare actual monitored and server collected times

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Male

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital Clinical Trial Center	Seoul		Korea, Republic of	03080
2	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

SeungHwan Lee, Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT05182684

Other Study ID Numbers:

VP-100-ECG

First Posted:

Jan 10, 2022

Last Update Posted:

Jan 10, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arrhythmias, Cardiac

Study Results

No Results Posted as of Jan 10, 2022