Suspected ArrhythmiaNCT07722026
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 study testing MEMO Patch V2 and 24-Hour Holter Monitor in people with Suspected Arrhythmia and Palpitations, run by HUINNO Co., Ltd at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Suspected Arrhythmia, Palpitations, Dizziness
- What is being tested?
- MEMO Patch V2 and 24-Hour Holter Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2021to 5 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 19 to 80 years.
- 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.
- Participants able to wear MEMO Patch V2 for 14 days.
- Participants who received a detailed explanation of the study, fully understood it, and voluntarily provided written informed consent.
Who cannot join
- History of allergic reactions to adhesive products.
- 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.
- Any other condition that, in the investigator's judgment, made the participant unsuitable for study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Suspected Arrhythmia, Palpitations, Dizziness, Cryptogenic Ischemic Stroke, Transient Ischemic Attack
- Being tested
- MEMO Patch V2, 24-Hour Holter Monitor
- Keywords
- arrhythmia, ECG, electrocardiography, wearable ECG, patch ECG, MEMO Patch V2, Holter monitor, palpitations, dizziness
- Medical subject headings
- Dizziness, Ischemic Stroke, Ischemic Attack, Transient, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEMO Patch V2Device
Also called MEMO Patch
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.
24-Hour Holter MonitorDevice
Also called Holter Monitor, 24-Hour Ambulatory ECG
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.
| Study group | Role | What they receive |
|---|---|---|
| MEMO Patch V2 and 24-Hour Holter Monitoring | Experimental | Participants underwent simultaneous ECG monitoring with MEMO Patch V2 for up to 14 days and a conventional Holter monitor for 24 hours. Receives: Device: MEMO Patch V2; Device: 24-Hour Holter Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From device application on Day 0 through completion of MEMO Patch V2 monitoring, up to 14 days
Secondary outcomes (3)
ECG Signal Quality
The percentage of analyzable MEMO Patch V2 recording time after excluding noise signals.
Measured: 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.
Measured: 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.
Measured: Day 21 ± 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Sep 2021
- Primary completion5 Jul 2022
- Study completion5 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suspected 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 participants underwent simultaneous monitoring with MEMO Patch V2 and a conventional 24-hour Holter monitor. Within-participant diagnostic yields were compared.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- HUINNO Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jong-Il Choi, Principal investigator, MD, Division of Cardiology, Korea University Anam HospitalIl-Young Oh, Principal investigator, MD, Division of Cardiology, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722026
- Sponsor's protocol ID
- HMP0001
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 23 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07722026
- Acronym / sponsor ID
- HMP0001
- Conditions
- Suspected Arrhythmia, Palpitations, Dizziness, Cryptogenic Ischemic Stroke, Transient Ischemic Attack
- Keywords
- arrhythmia, ECG, electrocardiography, wearable ECG, patch ECG, MEMO Patch V2, Holter monitor, palpitations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- HUINNO Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants underwent simultaneous monitoring with MEMO Patch V2 and a conventional 24-hour Holter monitor. Within-participant diagnostic yields were compared.
| Arm | Type | Receives |
|---|---|---|
| MEMO Patch V2 and 24-Hour Holter Monitoring | Experimental | Device: MEMO Patch V2, Device: 24-Hour Holter MonitorParticipants underwent simultaneous ECG monitoring with MEMO Patch V2 for up to 14 days and a conventional Holter monitor for 24 hours. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 19 to 80 years.
- 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.
- Participants able to wear MEMO Patch V2 for 14 days.
- Participants who received a detailed explanation of the study, fully understood it, and voluntarily provided written informed consent.
Key exclusion criteria (3 listed)
- History of allergic reactions to adhesive products.
- 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.
- Any other condition that, in the investigator's judgment, made the participant unsuitable for study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEMO Patch V2Also: MEMO PatchMEMO 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. | Device | MEMO Patch V2 and 24-Hour Holter Monitoring |
| 24-Hour Holter MonitorAlso: Holter Monitor, 24-Hour Ambulatory ECGA 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. | Device | MEMO Patch V2 and 24-Hour Holter Monitoring |
Primary outcome
Arrhythmia Detection Rate (%)
Time frame: From device application on Day 0 through completion of MEMO Patch V2 monitoring, up to 14 days
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.
3 secondary outcomes
ECG Signal Quality
Time frame: Up to 14 days
Participant Compliance
Time frame: Up to 14 days
Usability and Satisfaction
Time frame: Day 21 ± 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong-Il Choi principal investigator
MD, Division of Cardiology, Korea University Anam Hospital
Il-Young Oh principal investigator
MD, Division of Cardiology, Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEMO Patch V2 and 24-Hour Holter Monitor in people with Suspected Arrhythmia and Palpitations, run by HUINNO Co., Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arrhythmia Detection Rate (%) (time frame: From device application on Day 0 through completion of MEMO Patch V2 monitoring, up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.