7-Day MEMO Patch Monitoring for Arrhythmia Detection in Patients With Palpitations

An Exploratory Study to Evaluate Diagnostic Accuracy of a 7-day Adhesive Patch Electrocardiographic Monitoring for Detecting Arrhythmia in Patients With Palpitation.

"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."

Study Overview

• Status: Completed
• Conditions: Arrhythmia; Syncope; Palpitations
• Intervention / Treatment: Device: MEMO Patch; Device: 24-Hour Holter Monitor

Detailed Description

"Patients aged 19 years or older who visit the study site with symptoms suggestive of arrhythmia and require 24-hour ambulatory ECG monitoring will be screened after providing written informed consent.

At Visit 1, participants will simultaneously undergo conventional 24-hour Holter monitoring and 7-day ECG monitoring using the MEMO Patch. Participants will record the occurrence and timing of any symptoms in a symptom diary during the monitoring period.

The Holter monitor will be returned after 24 hours. Participants will continue wearing the MEMO Patch for an additional six days and return the device by mail after completion of the 7-day monitoring period.

After technical quality assessment, ECG recordings from both devices will be interpreted by cardiologists. Participants will return approximately one week after completion of monitoring to review the test results. Device usability and participant satisfaction will also be assessed using a questionnaire."

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea, 13620
    • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Participants must meet all of the following criteria:

  1. Adults aged 19 years or older who visit the study site during the study period with symptoms such as palpitations or syncope and are considered to require 24-hour ambulatory electrocardiographic monitoring.
  2. Able and willing to provide voluntary written informed consent.
  3. Able to wear the MEMO Patch™ continuously for 7 days.

Exclusion Criteria:

• Participants meeting any of the following criteria will be excluded:

  1. A self-reported history of an allergic skin reaction to previously used adhesive products.
  2. Planned electrical cardioversion, catheter ablation, or surgical treatment for an arrhythmia during the study period.

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 with 24-Hour Holter Monitoring; Participants simultaneously underwent conventional 24-hour Holter monitoring and continuous ECG monitoring using the MEMO Patch for seven days.

Device: 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.; Other Names: Adhesive ECG Patch; Device: 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.; Other Names: 24-Hour Ambulatory ECG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arrhythmia Detection	The presence of at least one of the following clinically significant arrhythmias as determined by ECG monitoring: Supraventricular tachycardia (≥3 consecutive beats, excluding atrial fibrillation/flutter) Atrial fibrillation/flutter (episode ≥30 seconds) Sinus pause (≥3 seconds) Second-degree (Mobitz type II) or third-degree atrioventricular block Ventricular tachycardia (≥3 consecutive beats) Polymorphic ventricular tachycardia or ventricular fibrillation	Visit 3 (approximately 14 [±3] days after device application at Visit 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Skin Adverse Events	The frequency, severity, time of onset, and seriousness of skin adverse events associated with MEMO Patch use will be evaluated.	Visit 3 (approximately 14 [±3] days after device application at Visit 1)
MEMO Patch Satisfaction and Usability Questionnaire	Participant satisfaction and usability of MEMO Patch will be evaluated using a 12-item questionnaire based on a 5-point Likert scale.	Visit 3 (approximately 14 [±3] days after device application at Visit 1)

Collaborators and Investigators

• Sponsor: HUINNO Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2020
• Primary Completion (Actual): July 29, 2021
• Study Completion (Actual): August 12, 2021

Study Registration Dates

• First Submitted: July 22, 2026
• First Submitted That Met QC Criteria: July 22, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Syncope; ECG Patch; Palpitations; Holter Monitoring; Wearable ECG; MEMO Patch; Ambulatory ECG Monitoring; Long-term ECG Monitoring
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Neurobehavioral Manifestations; Consciousness Disorders; Unconsciousness; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Arrhythmias, Cardiac; Syncope; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Electrodiagnosis; Monitoring, Physiologic; Electrocardiography; Monitoring, Ambulatory; Electrocardiography, Ambulatory
• Other Study ID Numbers: S1MP1-FP

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