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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

NCT07722026 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-07-23

No results posted yet for this study

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.

Conditions

  • Suspected Arrhythmia
  • Palpitations
  • Dizziness
  • Cryptogenic Ischemic Stroke
  • Transient Ischemic Attack

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • HUINNO Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Jong-Il Choi · MD, Division of Cardiology, Korea University Anam Hospital

  • Il-Young Oh · MD, Division of Cardiology, Seoul National University Bundang Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-07-05
Completion
2022-07-05

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07722026 on ClinicalTrials.gov