ArrhythmiaNCT07728552
7-Day MEMO Patch Monitoring for Arrhythmia Detection in Patients With Palpitations
A study testing MEMO Patch and 24-Hour Holter Monitor in people with Arrhythmia and Palpitations, run by HUINNO Co., Ltd at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Arrhythmia, Palpitations, Syncope
- What is being tested?
- MEMO Patch and 24-Hour Holter Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Mar 2020to 12 Aug 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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."
Read the 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."
- Conditions
- Arrhythmia, Palpitations, Syncope
- Being tested
- MEMO Patch, 24-Hour Holter Monitor
- Keywords
- MEMO Patch, ECG Patch, Ambulatory ECG Monitoring, Holter Monitoring, Palpitations, Syncope, Wearable ECG, Long-term ECG Monitoring
- Medical subject headings
- Arrhythmias, Cardiac, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEMO PatchDevice
Also called Adhesive ECG 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.
24-Hour Holter MonitorDevice
Also called 24-Hour Ambulatory ECG
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MEMO Patch; Device: 24-Hour Holter Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 3 (approximately 14 [±3] days after device application at Visit 1)
Secondary outcomes (2)
Frequency of Skin Adverse Events
The occurrence, frequency, severity, time of onset, and seriousness of skin adverse events associated with MEMO Patch use will be evaluated.
Measured: Visit 3 (approximately 14 [±3] days after device application at Visit 1)
MEMO Patch Satisfaction and Usability Questionnaire Score
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.
Measured: Visit 3 (approximately 14 [±3] days after device application at Visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start2 Mar 2020
- Primary completion29 Jul 2021
- Study completion12 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- HUINNO Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728552
- Sponsor's protocol ID
- S1MP1-FP
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.