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

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

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.

Study Overview

• Status: Completed
• Conditions: Transient Ischemic Attack; Dizziness; Palpitations; Cryptogenic Ischemic Stroke; Suspected Arrhythmia
• Intervention / Treatment: Device: MEMO Patch V2; Device: 24-Hour Holter Monitor

Detailed Description

This was a multicenter, non-randomized, controlled, open-label pilot clinical trial conducted at Korea University Anam Hospital and Seoul National University Bundang Hospital. Adults aged 19 to 80 years who required ECG monitoring because of suspected arrhythmia associated with palpitations or dizziness, or because of cryptogenic ischemic stroke or transient ischemic attack, were eligible. All participants underwent simultaneous application of a conventional 24-hour Holter monitor and MEMO Patch V2 on Day 0. The Holter monitor was removed and returned on Day 1, while MEMO Patch V2 continuously recorded a single-channel ECG for up to 14 days and was returned by courier. Participants attended an end-of-study visit on Day 21 ± 3 days. Effectiveness was evaluated by comparing arrhythmia detection rates and by assessing ECG signal quality, participant compliance, and device usability and satisfaction. Safety was evaluated based on skin-related adverse events occurring at the application site. A total of 150 participants were enrolled; the Full Analysis Set included 147 participants, the Per-Protocol Set included 141 participants, and the Safety Set included 150 participants.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea, 02841
    • Korea University Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults aged 19 to 80 years.
2. 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.
3. Participants able to wear MEMO Patch V2 for 14 days.
4. Participants who received a detailed explanation of the study, fully understood it, and voluntarily provided written informed consent.

Exclusion Criteria:

1. History of allergic reactions to adhesive products.
2. 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.
3. Any other condition that, in the investigator's judgment, made the participant unsuitable for study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MEMO Patch V2 and 24-Hour Holter Monitoring; 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; 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.; Other Names: MEMO Patch; 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.; Other Names: Holter Monitor; 24-Hour Ambulatory ECG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ECG Signal Quality	The percentage of analyzable MEMO Patch V2 recording time after excluding noise signals.	Up to 14 days
Participant Compliance	Compliance was calculated as actual wear time, excluding lead-off time, divided by the required total wear time of 336 hours, multiplied by 100.	Up to 14 days
Usability and Satisfaction	A 10-item questionnaire was scored on a 5-point scale and converted to a total score ranging from 0 to 100.	Day 21 ± 3 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin-Related Adverse Events	Number and percentage of participants with skin-related adverse events at the MEMO Patch V2 application site.	From Day 0 through Day 21 ± 3 days

Collaborators and Investigators

• Sponsor: HUINNO Co., Ltd
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): July 5, 2022
• Study Completion (Actual): July 5, 2022

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: dizziness; arrhythmia; ECG; electrocardiography; palpitations; Holter monitor; patch ECG; wearable ECG; MEMO Patch V2
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Brain Ischemia; Sensation Disorders; Stroke; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Ischemic Stroke; Ischemic Attack, Transient; Arrhythmias, Cardiac; Dizziness; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Electrodiagnosis; Monitoring, Physiologic; Electrocardiography; Monitoring, Ambulatory; Electrocardiography, Ambulatory
• Other Study ID Numbers: HMP0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data collected in this study are not planned to be shared with external researchers. Any future sharing would require separate sponsor approval and compliance with applicable privacy, ethical, and institutional requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No