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NCT Number: NCT07728552

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

"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."

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Key information

Conditions

Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Consciousness Disorders Heart Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Palpitations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Syncope Unconsciousness

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seoul, 13620, South Korea

About this study

"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."

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Adhesive ECG Patch

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.

Other names: 24-Hour Ambulatory ECG

Primary outcomes

  1. Rate of Participants with Clinically Significant Arrhythmia

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

    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.

Secondary outcomes

  1. Frequency of Skin Adverse Events

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

    The occurrence, frequency, severity, time of onset, and seriousness of skin adverse events associated with MEMO Patch use will be evaluated.

  2. MEMO Patch Satisfaction and Usability Questionnaire Score

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

    Participant satisfaction and usability of MEMO Patch will be evaluated using a 12-item questionnaire based on a 5-point Likert scale, with scores ranging from 1 to 5. Higher scores indicate better satisfaction and usability.

Sponsors and collaborators

Lead sponsor

HUINNO Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 27, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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