Heart DiseasesNCT07725445
Evaluation of an AI-Based Lightweight ECG Telemetry Monitoring System
A study testing MEMO Patch in people with Heart Diseases and Cardiac Surgery, run by HUINNO Co., Ltd at 1 site in South Korea.
Trial summary
This study aims to evaluate the clinical applicability of the AI-based lightweight ECG monitoring system (MEMO Patch Plus) as a telemetry ECG monitoring system in patients undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Heart Diseases, Cardiac Surgery, Cardiac Arrhythmias
- What is being tested?
- MEMO Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Sep 2022to 30 Nov 2023
- 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
- Patients undergoing cardiac surgery for cardiac diseases, including aortic valve stenosis, pulmonary valve regurgitation, mitral valve stenosis, mitral valve regurgitation, acute myocardial infarction, unstable angina, stable angina, aortic aneurysm, aortic dissection, atrial septal defect, cardiac tumor, and atrial fibrillation
- Patients who voluntarily decide to participate in this clinical study and provide written informed consent
Who cannot join
- Patients younger than 19 years of age or 80 years of age or older
- Pregnant or lactating women
- Patients whom the investigator judges to be unsuitable for participation in this clinical study or whose participation may increase the risk to the patient
- Patients with sensitive skin, an allergic reaction to silicone, or skin rash at the intended device application site
- Patients who, due to cognitive vulnerability, are judged to be unable to understand the information related to the study, appreciate its significance, and make an independent voluntary decision regarding participation Hemodynamically unstable patients, including those receiving extracorporeal membrane oxygenation (ECMO) or high-dose inotropic support (e.g., epinephrine)
- Patients whom the investigator considers inappropriate for participation in this clinical study for ethical reasons or because participation may affect the study results. Specific reasons will be documented in the source records.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation the Lightweight ECG Monitoring System Based on Al as a Telemetry ECG Monitoring System
This study aims to evaluate the clinical applicability of the AI-based lightweight ECG monitoring system (MEMO Patch Plus) as a telemetry ECG monitoring system in patients undergoing cardiac surgery. Participants will wear the MEMO Patch Plus for at least 48 hours and up to 168 hours after transfer from the intensive care unit to the general ward. The study will evaluate real-time ECG transmission, arrhythmia detection, device usability, and safety to generate preliminary evidence supporting future clinical studies.
Read the detailed description
Participants who provide written informed consent and meet all eligibility criteria will be enrolled in this prospective, single-arm study.
After transfer from the intensive care unit to the general ward, participants will wear the MEMO Patch Plus for continuous electrocardiographic (ECG) monitoring for a minimum of 48 hours and up to 168 hours. During the study period, the MEMO Patch Plus will continuously transmit ECG data to the monitoring system, allowing real-time remote monitoring by healthcare professionals. Clinical information related to arrhythmia detection, ECG transmission performance, and device operation will be collected throughout the monitoring period.
The primary outcome is the real-time ECG transmission rate. Secondary outcomes include the arrhythmia detection rate, device usability assessed by participants using a questionnaire, and safety assessed by device-related adverse events, including skin irritation. The results of this exploratory study will be used to evaluate the clinical applicability of the MEMO Patch Plus as a telemetry ECG monitoring system and to provide preliminary evidence for future clinical studies.
- Conditions
- Heart Diseases, Cardiac Surgery, Cardiac Arrhythmias
- Being tested
- MEMO Patch
- Keywords
- MEMO Patch Plus, Telemetry Electrocardiography, Remote ECG Monitoring, Wearable ECG, Arrhythmia Detection, Cardiac Surgery, Cardiac Telemetry
- Medical subject headings
- Heart Diseases, Arrhythmias, Cardiac
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
The MEMO Patch Plus is a wearable adhesive ECG monitoring device for continuous cardiac rhythm monitoring. The device continuously acquires single-channel ECG signals and wirelessly transmits the data to a remote monitoring system, enabling real-time ECG monitoring and arrhythmia detection by healthcare professionals. The device is intended for continuous cardiac rhythm monitoring in hospitalized patients.
| Study group | Role | What they receive |
|---|---|---|
| Remote MEMO Patch Plus Monitoring | Experimental | Participants wear the MEMO Patch Plus after transfer from the intensive care unit to the general ward for continuous telemetry electrocardiographic (ECG) monitoring. The device is worn for a minimum of 48 hours and up to 168 hours, during which ECG data are continuously transmitted to the monitoring system for real-time remote monitoring. The study evaluates the clinical applicability of the MEMO Patch Plus by assessing the real-time ECG transmission rate, arrhythmia detection rate, participant-reported device usability, and device-related safety. Receives: Device: MEMO Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-time ECG Transmission Rate
The real-time ECG transmission rate of the MEMO Patch Plus will be evaluated during the monitoring period. The transmission rate is defined as the proportion of successfully transmitted ECG data relative to the total monitoring time.
Measured: During continuous ECG monitoring (minimum 48 hours to maximum 168 hours)
Secondary outcomes (2)
Arrhythmia Detection Rate
The arrhythmia detection rate of the MEMO Patch Plus will be evaluated during the monitoring period based on clinically identified arrhythmia events.
Measured: End-of-study visit (7 to 30 days after hospital discharge)
Device Usability Questionnaire Score
Device usability will be evaluated using a participant-completed usability questionnaire after completion of the monitoring period. The questionnaire uses a 5-point Likert scale, with scores ranging from 1 to 5. Higher scores indicate better device usability.
Measured: Visit 3 (48 to 168 hours after device application)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start28 Sep 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies 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 who meet the eligibility criteria will wear the MEMO Patch Plus after transfer from the intensive care unit to the general ward. The device will be used for continuous electrocardiographic (ECG) monitoring for a minimum of 48 hours and up to 168 hours. During the monitoring period, ECG data will be transmitted in real time to the monitoring system for remote observation. The study will evaluate the real-time ECG transmission rate, arrhythmia detection rate, device usability assessed by participants, and device-related safety to assess the clinical applicability of the MEMO Patch Plus as a telemetry ECG monitoring system.
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT07725445
- Sponsor's protocol ID
- S1MP1-TM
- Status last verified
- Jul 2026
- First submitted
- 21 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Lightweight ECG Monitoring System Based on Al as a Telemetry ECG Monitoring System
- ClinicalTrials.gov ID
- NCT07725445
- Acronym / sponsor ID
- S1MP1-TM
- Conditions
- Heart Diseases, Cardiac Surgery, Cardiac Arrhythmias
- Keywords
- MEMO Patch Plus, Telemetry Electrocardiography, Remote ECG Monitoring, Wearable ECG, Arrhythmia Detection, Cardiac Surgery, Cardiac Telemetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- HUINNO Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 24 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 study aims to evaluate the clinical applicability of the AI-based lightweight ECG monitoring system (MEMO Patch Plus) as a telemetry ECG monitoring system in patients undergoing cardiac surgery. Participants will wear the MEMO Patch Plus for at least 48 hours and up to 168 hours after transfer from the intensive care unit to the general ward. The study will evaluate real-time ECG transmission, arrhythmia detection, device usability, and safety to generate preliminary evidence supporting future clinical studies.
Detailed description
Participants who provide written informed consent and meet all eligibility criteria will be enrolled in this prospective, single-arm study.
After transfer from the intensive care unit to the general ward, participants will wear the MEMO Patch Plus for continuous electrocardiographic (ECG) monitoring for a minimum of 48 hours and up to 168 hours. During the study period, the MEMO Patch Plus will continuously transmit ECG data to the monitoring system, allowing real-time remote monitoring by healthcare professionals. Clinical information related to arrhythmia detection, ECG transmission performance, and device operation will be collected throughout the monitoring period.
The primary outcome is the real-time ECG transmission rate. Secondary outcomes include the arrhythmia detection rate, device usability assessed by participants using a questionnaire, and safety assessed by device-related adverse events, including skin irritation. The results of this exploratory study will be used to evaluate the clinical applicability of the MEMO Patch Plus as a telemetry ECG monitoring system and to provide preliminary evidence for future clinical studies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants who meet the eligibility criteria will wear the MEMO Patch Plus after transfer from the intensive care unit to the general ward. The device will be used for continuous electrocardiographic (ECG) monitoring for a minimum of 48 hours and up to 168 hours. During the monitoring period, ECG data will be transmitted in real time to the monitoring system for remote observation. The study will evaluate the real-time ECG transmission rate, arrhythmia detection rate, device usability assessed by participants, and device-related safety to assess the clinical applicability of the MEMO Patch Plus as a telemetry ECG monitoring system.
| Arm | Type | Receives |
|---|---|---|
| Remote MEMO Patch Plus Monitoring | Experimental | Device: MEMO PatchParticipants wear the MEMO Patch Plus after transfer from the intensive care unit to the general ward for continuous telemetry electrocardiographic (ECG) monitoring. The device is worn for a minimum of 48 hours and up to 168 hours, during which ECG data are continuously transmitted to the monitoring system for real-time remote monitoring. The study evaluates the clinical applicability of the MEMO Patch Plus by assessing the real-time ECG transmission rate, arrhythmia detection rate, participant-reported device usability, and device-related safety. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing cardiac surgery for cardiac diseases, including aortic valve stenosis, pulmonary valve regurgitation, mitral valve stenosis, mitral valve regurgitation, acute myocardial infarction, unstable angina, stable angina, aortic aneurysm, aortic dissection, atrial septal defect, cardiac tumor, and atrial fibrillation
- Patients who voluntarily decide to participate in this clinical study and provide written informed consent
Key exclusion criteria (6 listed)
- Patients younger than 19 years of age or 80 years of age or older
- Pregnant or lactating women
- Patients whom the investigator judges to be unsuitable for participation in this clinical study or whose participation may increase the risk to the patient
- Patients with sensitive skin, an allergic reaction to silicone, or skin rash at the intended device application site
- Patients who, due to cognitive vulnerability, are judged to be unable to understand the information related to the study, appreciate its significance, and make an independent voluntary decision regarding participation Hemodynamically unstable patients, including those receiving extracorporeal membrane oxygenation (ECMO) or high-dose inotropic support (e.g., epinephrine)
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 PatchAlso: Adhesive ECG PatchThe MEMO Patch Plus is a wearable adhesive ECG monitoring device for continuous cardiac rhythm monitoring. The device continuously acquires single-channel ECG signals and wirelessly transmits the data to a remote monitoring system, enabling real-time ECG monitoring and arrhythmia detection by healthcare professionals. The device is intended for continuous cardiac rhythm monitoring in hospitalized patients. | Device | Remote MEMO Patch Plus Monitoring |
Primary outcome
Real-time ECG Transmission Rate
Time frame: During continuous ECG monitoring (minimum 48 hours to maximum 168 hours)
The real-time ECG transmission rate of the MEMO Patch Plus will be evaluated during the monitoring period. The transmission rate is defined as the proportion of successfully transmitted ECG data relative to the total monitoring time.
2 secondary outcomes
Arrhythmia Detection Rate
Time frame: End-of-study visit (7 to 30 days after hospital discharge)
Device Usability Questionnaire Score
Time frame: Visit 3 (48 to 168 hours after device application)
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 30 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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Heart Diseases and Cardiac Surgery, 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 2 inclusion and 6 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 30 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?
Real-time ECG Transmission Rate (time frame: During continuous ECG monitoring (minimum 48 hours to maximum 168 hours)). 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 30 Jul 2026.