The Collection and Transmission of Electrocardiogram Using a Wearable Device

December 21, 2021 updated by: SeungHwan Lee, Seoul National University Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: SeungHwan Lee, Professor
  • Phone Number: 0694 82-02-2072-0694
  • Email: hwan8495@snu.ac.kr

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital Clinical Trial Center
        • Contact:
        • Contact:
          • Kyung-Sang Yu, MD, PhD
          • Phone Number: +82-2-2072-1920
          • Email: ksyu@snu.ac.kr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of data collected
Time Frame: 6 hours
Compare actual monitored and server collected times
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The comparison of ventricular rate
Time Frame: 6 hours
Compare actual monitored and server collected ventricular rate
6 hours
The comparison of abnormal events
Time Frame: 6 hours
Compare patient-reported adverse events with abnormal beats collected by a central server
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2021

Primary Completion (Anticipated)

June 21, 2022

Study Completion (Anticipated)

June 21, 2022

Study Registration Dates

First Submitted

October 25, 2021

First Submitted That Met QC Criteria

December 21, 2021

First Posted (Actual)

January 10, 2022

Study Record Updates

Last Update Posted (Actual)

January 10, 2022

Last Update Submitted That Met QC Criteria

December 21, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-100-ECG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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