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7-Day MEMO Patch Monitoring for Arrhythmia Detection in Patients With Palpitations
Sponsor: HUINNO Co., Ltd
Summary
"This exploratory prospective clinical study aims to evaluate the diagnostic yield of a 7-day adhesive electrocardiographic (ECG) monitoring device (MEMO Patch) in detecting cardiac arrhythmias in patients presenting with palpitations. Participants who require 24-hour Holter monitoring because of symptoms such as palpitations or dizziness will simultaneously wear a conventional 24-hour Holter monitor and the MEMO Patch. The Holter monitor will be removed after 24 hours, while the MEMO Patch will continue monitoring for a total of 7 days. ECG recordings will be evaluated by cardiologists after technical quality assessment. The study will assess arrhythmia detection, device-related skin adverse events, and participant usability and satisfaction."
Official title: An Exploratory Study to Evaluate Diagnostic Accuracy of a 7-day Adhesive Patch Electrocardiographic Monitoring for Detecting Arrhythmia in Patients With Palpitation.
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2020-03-02
Completion Date
2021-08-12
Last Updated
2026-07-27
Healthy Volunteers
No
Conditions
Interventions
MEMO Patch
MEMO Patch is a wearable single-lead adhesive electrocardiographic (ECG) monitoring device for continuous ECG recording. The device is applied simultaneously with a conventional 24-hour Holter monitor at Visit 1 and is worn continuously for 7 days.
24-Hour Holter Monitor
A conventional 24-hour ambulatory electrocardiographic (ECG) monitor is applied simultaneously with the MEMO Patch at Visit 1 and is used for continuous ECG recording for approximately 24 hours. The Holter monitor is removed at Visit 2.
Locations (1)
Seoul National University Bundang Hospital
Seoul, South Korea