ArrhythmiasNCT07260721
Evaluation of a Single-lead ECG Patch-based Telemetry System for In-hospital Monitoring
A study testing MEMO-Cue-based telemetry monitoring in people with Arrhythmias and Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial summary
"This investigator-initiated, prospective, single-center clinical study evaluates the performance and clinical utility of a single-lead electrocardiogram (ECG) patch-based telemetry system for hospitalized patients who require in-hospital telemetry ECG monitoring. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Arrhythmias, Atrial Fibrillation, Ventricular Tachycardia
- What is being tested?
- MEMO-Cue-based telemetry monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults aged 19 years or older who provide written informed consent for participation.
- Patients requiring in-hospital telemetry electrocardiogram monitoring during hospitalization.
Who cannot join
- Known hypersensitivity or allergic reaction to adhesives or hydrogel.
- Presence of skin wounds at the intended application site of the investigational device.
- Implanted cardiac electronic devices such as pacemakers, ICDs, or other CIEDs
- Current or past history of skin cancer, rash, dermatologic disorders, keloid formation, or skin injury.
- Any condition judged by the investigator to increase risk or make participation inappropriate.
- Cognitive impairment that precludes understanding of study information or voluntary consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigator-initiated Trial to Evaluate the Performance and Utility of a Single-lead Electrocardiogram Patch-based Telemetry System in Patients Requiring In-hospital Telemetry Electrocardiogram Monitoring During Hospitalization
"This investigator-initiated, prospective, single-center clinical study evaluates the performance and clinical utility of a single-lead electrocardiogram (ECG) patch-based telemetry system for hospitalized patients who require in-hospital telemetry ECG monitoring. The system integrates real-time centralized surveillance (MEMO-Cue) with post-hoc analytic review (MEMO-Care) using ECG signals recorded by the MEMO Patch M, aiming to enable timely recognition of clinically important arrhythmias and to inform treatment decisions under routine inpatient conditions.
Adults (≥19 years) indicated for continuous ECG monitoring during admission are enrolled after written informed consent, with a planned sample size of 100 to yield approximately 90 evaluable participants (10% anticipated dropout). The design does not include randomization or blinding. Study procedures include a screening visit (eligibility and baseline data), an inpatient monitoring period of at least 12 hours and up to 8 days with simultaneous MEMO-Cue monitoring and MEMO Patch M recording, and an end-of-visit assessment when MEMO-Care analytic results become available. Concomitant therapies deemed clinically necessary are permitted and documented, and adverse events are prospectively assessed.
Read more
Clinical utility endpoints quantify care impact and timeliness: (1) rate of treatment plan changes (e.g., initiation or modification of anticoagulants or antiarrhythmic drugs, cardioversion scheduling, device implantation, or other actions); (2) time to recognition (days) of major arrhythmias-atrial fibrillation (AF), ventricular tachycardia (VT), pause, ventricular premature complex (VPC), and supraventricular tachycardia (SVT)-based on MEMO-Cue alarms or MEMO-Care results with objective confirmation; (3) reduction ratio in recognition time when identified earlier by MEMO-Cue versus MEMO-Care; and (4) proportion of participants with shortened recognition time by MEMO-Cue.
Clinical performance endpoints assess detection characteristics and agreement between MEMO-Cue alarms and MEMO-Care findings: (1) clinical sensitivity (true positive / [true positive + false negative]); (2) precision, i.e., positive predictive value (true positive / [true positive + false positive]); and (3) positive concordance rate (proportion of MEMO-Care-detected arrhythmias alerted by MEMO-Cue). Safety is captured as treatment-emergent adverse events after device application, including device-related skin reactions, detachment, or signal dropouts, with severity graded per NCI-CTCAE v5.0 and relationship to device recorded.
By characterizing real-time patch-based telemetry alongside analytic review and its influence on diagnostic timing and management, the study aims to generate practical evidence supporting feasibility, reliability, and workflow compatibility of single-lead patch telemetry for in-hospital ECG monitoring.
- Conditions
- Arrhythmias, Atrial Fibrillation, Ventricular Tachycardia, Supraventricular Tachycardia, Bradycardia, Telemetry
- Being tested
- MEMO-Cue-based telemetry monitoring
- Medical subject headings
- Arrhythmias, Cardiac, Atrial Fibrillation, Tachycardia, Ventricular, Tachycardia, Supraventricular, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEMO-Cue-based telemetry monitoringDevice
In-hospital telemetry electrocardiogram monitoring using the MEMO-Cue system, which integrates a single-lead patch-type Holter device (MEMO Patch M) with a central monitoring software (MEMO-Cue) and an analysis platform (MEMO Care). Participants requiring continuous ECG telemetry during hospitalization are monitored for at least 12 hours and up to 8 days to evaluate the system's clinical utility and performance in real-time arrhythmia detection compared with retrospective analysis using MEMO Care.
| Study group | Role | What they receive |
|---|---|---|
| MEMO-Cue | Experimental | Participants receive continuous in-hospital ECG monitoring using the MEMO-Cue system, which combines a single-lead patch device with real-time telemetry software. Monitoring lasts 12 hours to 8 days, and arrhythmia detection performance is compared with retrospective analysis using MEMO Care. Receives: Device: MEMO-Cue-based telemetry monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical decision change rate based on MEMO-Cue monitoring
Clinical utility will be evaluated by rate of change in treatment plans (%)
Measured: From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical decision change rate based on MEMO-Cue monitoring
Clinical utility will be evaluated by time to recognition of major arrhythmias (days)
Measured: From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical decision change rate based on MEMO-Cue monitoring
Clinical utility will be evaluated by reduction rate in arrhythmia recognition time (%)
Measured: From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical decision change rate based on MEMO-Cue monitoring
Clinical utility will be evaluated by proportion of participants with shortened recognition time
Measured: From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical decision change rate based on MEMO-Cue monitoring
Clinical performance will be assessed by clinical sensitivity (%)
Measured: From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical decision change rate based on MEMO-Cue monitoring
Clinical performance will be assessed by precision (%)
Measured: From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical decision change rate based on MEMO-Cue monitoring
Clinical performance will be assessed by positive concordance rate (%)
Measured: From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiasStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260721
- Sponsor's protocol ID
- 1-2025-0048
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator-initiated Trial to Evaluate the Performance and Utility of a Single-lead Electrocardiogram Patch-based Telemetry System in Patients Requiring In-hospital Telemetry Electrocardiogram Monitoring During Hospitalization
- ClinicalTrials.gov ID
- NCT07260721
- Acronym / sponsor ID
- 1-2025-0048
- Conditions
- Arrhythmias, Atrial Fibrillation, Ventricular Tachycardia, Supraventricular Tachycardia, Bradycardia, Telemetry
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 3 Dec 2025 (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 investigator-initiated, prospective, single-center clinical study evaluates the performance and clinical utility of a single-lead electrocardiogram (ECG) patch-based telemetry system for hospitalized patients who require in-hospital telemetry ECG monitoring. The system integrates real-time centralized surveillance (MEMO-Cue) with post-hoc analytic review (MEMO-Care) using ECG signals recorded by the MEMO Patch M, aiming to enable timely recognition of clinically important arrhythmias and to inform treatment decisions under routine inpatient conditions.
Adults (≥19 years) indicated for continuous ECG monitoring during admission are enrolled after written informed consent, with a planned sample size of 100 to yield approximately 90 evaluable participants (10% anticipated dropout). The design does not include randomization or blinding. Study procedures include a screening visit (eligibility and baseline data), an inpatient monitoring period of at least 12 hours and up to 8 days with simultaneous MEMO-Cue monitoring and MEMO Patch M recording, and an end-of-visit assessment when MEMO-Care analytic results become available. Concomitant therapies deemed clinically necessary are permitted and documented, and adverse events are prospectively assessed.
Clinical utility endpoints quantify care impact and timeliness: (1) rate of treatment plan changes (e.g., initiation or modification of anticoagulants or antiarrhythmic drugs, cardioversion scheduling, device implantation, or other actions); (2) time to recognition (days) of major arrhythmias-atrial fibrillation (AF), ventricular tachycardia (VT), pause, ventricular premature complex (VPC), and supraventricular tachycardia (SVT)-based on MEMO-Cue alarms or MEMO-Care results with objective confirmation; (3) reduction ratio in recognition time when identified earlier by MEMO-Cue versus MEMO-Care; and (4) proportion of participants with shortened recognition time by MEMO-Cue.
Clinical performance endpoints assess detection characteristics and agreement between MEMO-Cue alarms and MEMO-Care findings: (1) clinical sensitivity (true positive / [true positive + false negative]); (2) precision, i.e., positive predictive value (true positive / [true positive + false positive]); and (3) positive concordance rate (proportion of MEMO-Care-detected arrhythmias alerted by MEMO-Cue). Safety is captured as treatment-emergent adverse events after device application, including device-related skin reactions, detachment, or signal dropouts, with severity graded per NCI-CTCAE v5.0 and relationship to device recorded.
By characterizing real-time patch-based telemetry alongside analytic review and its influence on diagnostic timing and management, the study aims to generate practical evidence supporting feasibility, reliability, and workflow compatibility of single-lead patch telemetry for in-hospital ECG monitoring.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MEMO-Cue | Experimental | Device: MEMO-Cue-based telemetry monitoringParticipants receive continuous in-hospital ECG monitoring using the MEMO-Cue system, which combines a single-lead patch device with real-time telemetry software. Monitoring lasts 12 hours to 8 days, and arrhythmia detection performance is compared with retrospective analysis using MEMO Care. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 19 years or older who provide written informed consent for participation.
- Patients requiring in-hospital telemetry electrocardiogram monitoring during hospitalization.
Key exclusion criteria (6 listed)
- Known hypersensitivity or allergic reaction to adhesives or hydrogel.
- Presence of skin wounds at the intended application site of the investigational device.
- Implanted cardiac electronic devices such as pacemakers, ICDs, or other CIEDs
- Current or past history of skin cancer, rash, dermatologic disorders, keloid formation, or skin injury.
- Any condition judged by the investigator to increase risk or make participation inappropriate.
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-Cue-based telemetry monitoringIn-hospital telemetry electrocardiogram monitoring using the MEMO-Cue system, which integrates a single-lead patch-type Holter device (MEMO Patch M) with a central monitoring software (MEMO-Cue) and an analysis platform (MEMO Care). Participants requiring continuous ECG telemetry during hospitalization are monitored for at least 12 hours and up to 8 days to evaluate the system's clinical utility and performance in real-time arrhythmia detection compared with retrospective analysis using MEMO Care. | Device | MEMO-Cue |
Primary outcome
Clinical decision change rate based on MEMO-Cue monitoring
Time frame: From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical utility will be evaluated by rate of change in treatment plans (%)
Clinical decision change rate based on MEMO-Cue monitoring
Time frame: From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical utility will be evaluated by time to recognition of major arrhythmias (days)
Clinical decision change rate based on MEMO-Cue monitoring
Time frame: From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical utility will be evaluated by reduction rate in arrhythmia recognition time (%)
Clinical decision change rate based on MEMO-Cue monitoring
Time frame: From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical utility will be evaluated by proportion of participants with shortened recognition time
Clinical decision change rate based on MEMO-Cue monitoring
Time frame: From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical performance will be assessed by clinical sensitivity (%)
Clinical decision change rate based on MEMO-Cue monitoring
Time frame: From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical performance will be assessed by precision (%)
Clinical decision change rate based on MEMO-Cue monitoring
Time frame: From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical performance will be assessed by positive concordance rate (%)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
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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.
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-Cue-based telemetry monitoring in people with Arrhythmias and Atrial Fibrillation, run by Yonsei University 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: opening soon, as of the sponsor's last update on 3 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical decision change rate based on MEMO-Cue monitoring (time frame: From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.). The study lists 7 primary outcomes in all. 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 3 Dec 2025.