Status:
UNKNOWN
Diagnostic Validation of Wearable ECG Monitoring Patch, ATP-C120
Lead Sponsor:
Seoul National University Bundang Hospital
Collaborating Sponsors:
Kyungpook National University Hospital
Conditions:
Atrial Fibrillation New Onset
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
A new wearable patch-type device, ATP-C120 (ATsens, Seongnam, Korea) is a novel, single-lead ECG monitoring device and can continuously monitor the ECG signal for upto 11 days. This study is designed ...
Detailed Description
The prevention of stroke associated with atrial fibrillation is a leading global health concern. This devastating event is largely preventable with anticoagulant therapy. Therefore, the early detectio...
Eligibility Criteria
Inclusion
- patients who provide written and informed consent to participate
- patients whose calculated CHA2DS2-VASc score is ≥ 2
Exclusion
- subjects previously diagnosed with atrial fibrillation
- subjects implanted pacemaker, cardioverter-defibrillator, or any electrical devices
- subjects had skin problems such as allergic contact dermatitis
- female patients who are pregnant, or lactating status.
Key Trial Info
Start Date :
November 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT04857268
Start Date
November 13 2020
End Date
December 31 2023
Last Update
April 26 2021
Active Locations (2)
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1
Seoul National Universtiy Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463-707
2
Kyungpook National University Hospital
Daegu, South Korea