The 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
1 other identifier
interventional
50
1 country
2
Brief Summary
A multi-center clinical trial to explore the status of collection and transmission of electrocardiogram using a wearable device
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2021
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2021
CompletedStudy Start
First participant enrolled
October 26, 2021
CompletedFirst Posted
Study publicly available on registry
January 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2022
CompletedJanuary 10, 2022
December 1, 2021
8 months
October 25, 2021
December 21, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The proportion of data collected
Compare actual monitored and server collected times
6 hours
Secondary Outcomes (2)
The comparison of ventricular rate
6 hours
The comparison of abnormal events
6 hours
Study Arms (1)
Single arm
EXPERIMENTALElectrocardiograms were measured by VP-100 for more than 6 hours and transmitted to a central server.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Healthy adult male volunteers who can use an Android smartphone.
- The subjects who voluntarily agree to participate and give written informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Seoul National University Hospital Clinical Trial Center
Seoul, 03080, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Related Publications (1)
Huh KY, Jeong SI, Yoo H, Piao M, Ryu H, Kim H, Yoon YR, Seong SJ, Lee S, Kim KH. Lessons from a multicenter clinical trial with an approved wearable electrocardiogram: issues and practical considerations. Transl Clin Pharmacol. 2022 Jun;30(2):87-98. doi: 10.12793/tcp.2022.30.e7. Epub 2022 May 24.
PMID: 35800668DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 25, 2021
First Posted
January 10, 2022
Study Start
October 26, 2021
Primary Completion
June 21, 2022
Study Completion
June 21, 2022
Last Updated
January 10, 2022
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share