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This Exploratory Medical Device Study Evaluated the Arrhythmia Diagnostic Yield of MEMO Patch V2, a Wearable Patch-type Electrocardiographic Monitor, in Adults With Suspected Arrhythmia Who Presented With Symptoms Such as Palpitations or Dizziness, or Who Had Cryptogenic Ischemic Stroke or Transient
Sponsor: HUINNO Co., Ltd
Summary
This exploratory medical device study evaluated the arrhythmia diagnostic yield of MEMO Patch V2, a wearable patch-type electrocardiographic monitor, in adults with suspected arrhythmia who presented with symptoms such as palpitations or dizziness, or who had cryptogenic ischemic stroke or transient ischemic attack. The diagnostic yield of MEMO Patch V2 was compared with that of conventional 24-hour ambulatory electrocardiography (Holter monitoring). The study also assessed ECG signal quality, participant compliance, usability and satisfaction, and skin-related adverse events. The findings were intended to provide preliminary data for planning a future large-scale clinical study.
Official title: A Multicenter, Non-randomized, Controlled, Open-label Pilot Clinical Trial to Compare and Evaluate the Arrhythmia Diagnostic Performance of MEMO Patch V2 and 24-Hour Ambulatory Electrocardiography in Patients With Suspected Arrhythmia Presenting With Palpitations or Dizziness
Key Details
Gender
All
Age Range
19 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2021-09-01
Completion Date
2022-07-05
Last Updated
2026-07-23
Healthy Volunteers
No
Conditions
Interventions
MEMO Patch V2
MEMO Patch V2 is a wearable, single-channel patch-type ECG monitoring device intended for long-term ambulatory ECG recording. The device was applied on Day 0 and used for continuous ECG monitoring for up to 14 days. ECG data were stored and transferred for review through the MEMO ECG Webviewer. Electrode patches were replaced every 24 hours, and the device was returned by courier after monitoring.
24-Hour Holter Monitor
A conventional ambulatory electrocardiographic monitor was applied simultaneously with MEMO Patch V2 on Day 0 and used for continuous ECG recording for approximately 24 hours. The device was removed and returned at the clinical site on Day 1.
Locations (1)
Korea University Anam Hospital
Seoul, South Korea