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 | Completed

• 1 other identifier: HMP0001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

arrhythmia; ECG; electrocardiography; wearable ECG; patch ECG; MEMO Patch V2; Holter monitor; palpitations; dizziness

Outcome Measures

Primary Outcomes (1)

• Arrhythmia Detection Rate (%)

  The proportion of participants diagnosed with at least one arrhythmia using MEMO Patch V2 was compared with the proportion diagnosed using the 24-hour Holter monitor. Arrhythmias included premature atrial contraction, premature ventricular contraction, atrial tachycardia, atrial flutter, atrial fibrillation, paroxysmal supraventricular tachycardia, ventricular tachycardia, second- or third-degree atrioventricular block, sinus pause, and other arrhythmias. Comparisons included the total monitoring periods (Holter: 24 hours; MEMO Patch V2: at least 7 days) and the first 24 hours for both devices.

  From device application on Day 0 through completion of MEMO Patch V2 monitoring, up to 14 days

Secondary Outcomes (3)

• ECG Signal Quality

  Up to 14 days

• Participant Compliance

  Up to 14 days

• Usability and Satisfaction

  Day 21 ± 3 days

Other Outcomes (1)

• Skin-Related Adverse Events

  From Day 0 through Day 21 ± 3 days

Study Arms (1)

MEMO Patch V2 and 24-Hour Holter Monitoring

EXPERIMENTAL

Participants underwent simultaneous ECG monitoring with MEMO Patch V2 for up to 14 days and a conventional Holter monitor for 24 hours.

Device: MEMO Patch V2; Device: 24-Hour Holter Monitor

Interventions

MEMO Patch V2 DEVICE

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.

Also known as: MEMO Patch

MEMO Patch V2 and 24-Hour Holter Monitoring

24-Hour Holter Monitor DEVICE

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.

Also known as: Holter Monitor, 24-Hour Ambulatory ECG

MEMO Patch V2 and 24-Hour Holter Monitoring

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19 to 80 years.
• Participants who required ECG monitoring because of suspected arrhythmia associated with symptoms such as palpitations or dizziness; or participants with cryptogenic ischemic stroke or transient ischemic attack.
• Participants able to wear MEMO Patch V2 for 14 days.
• Participants who received a detailed explanation of the study, fully understood it, and voluntarily provided written informed consent.

You may not qualify if:

• History of allergic reactions to adhesive products.
• Participants who required inpatient management during the study because of atrial fibrillation, stroke, transient ischemic attack, another clinically significant condition as determined by the investigator, or a history of dehydration or syncope within 1 year before screening.
• Any other condition that, in the investigator's judgment, made the participant unsuitable for study participation.

Sponsors & Collaborators

• HUINNO Co., Ltd: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

MeSH Terms

Conditions

Dizziness; Ischemic Stroke; Ischemic Attack, Transient; Arrhythmias, Cardiac

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Heart Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Jong-Il Choi

  MD, Division of Cardiology, Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

• Il-Young Oh

  MD, Division of Cardiology, Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants underwent simultaneous monitoring with MEMO Patch V2 and a conventional 24-hour Holter monitor. Within-participant diagnostic yields were compared.

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start: September 1, 2021
• Primary Completion: July 5, 2022
• Study Completion: July 5, 2022
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)