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

NCT07728552 | Completed

• 1 other identifier: S1MP1-FP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

"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."

Conditions

Arrhythmia; Palpitations; Syncope

Keywords

MEMO Patch; ECG Patch; Ambulatory ECG Monitoring; Holter Monitoring; Palpitations; Syncope; Wearable ECG; Long-term ECG Monitoring

Outcome Measures

Primary Outcomes (1)

• Rate of Participants with Clinically Significant Arrhythmia

  The rate of participants diagnosed with at least one clinically significant arrhythmia will be evaluated based on ECG monitoring. Clinically significant arrhythmias include 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), and polymorphic ventricular tachycardia or ventricular fibrillation.

  Visit 3 (approximately 14 [±3] days after device application at Visit 1)

Secondary Outcomes (2)

• Frequency of Skin Adverse Events

  Visit 3 (approximately 14 [±3] days after device application at Visit 1)

• MEMO Patch Satisfaction and Usability Questionnaire Score

  Visit 3 (approximately 14 [±3] days after device application at Visit 1)

Study Arms (1)

MEMO Patch with 24-Hour Holter Monitoring

EXPERIMENTAL

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

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

Interventions

MEMO Patch DEVICE

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.

Also known as: Adhesive ECG Patch

MEMO Patch with 24-Hour Holter Monitoring

24-Hour Holter Monitor DEVICE

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.

Also known as: 24-Hour Ambulatory ECG

MEMO Patch with 24-Hour Holter Monitoring

Eligibility Criteria

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

You may qualify if:

• Participants must meet all of the following criteria:
• 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.
• Able and willing to provide voluntary written informed consent.
• Able to wear the MEMO Patch™ continuously for 7 days.

You may not qualify if:

• Participants meeting any of the following criteria will be excluded:
• A self-reported history of an allergic skin reaction to previously used adhesive products.
• Planned electrical cardioversion, catheter ablation, or surgical treatment for an arrhythmia during the study period.

Sponsors & Collaborators

• HUINNO Co., Ltd: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seoul, 13620, South Korea

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Syncope

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking was applied to participants or investigators.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All enrolled participants underwent simultaneous monitoring with a conventional 24-hour Holter monitor and the MEMO Patch. The Holter monitor was removed after 24 hours, whereas the MEMO Patch continued ECG monitoring for 7 days. Diagnostic yields were compared within participants.

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start: March 2, 2020
• Primary Completion: July 29, 2021
• Study Completion: August 12, 2021
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)