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A Multicenter, Randomized Controlled, Open, Prospective, Pilot Trial to Evaluate the Efficacy of MEMO Patch2 for Remote Monitoring in Detecting Atrial Fibrillation in Patient who Need External ECG Monitoring

A Multicenter, Randomized Controlled, Open, Prospective, Pilot Trial to Evaluate the Efficacy of MEMO Patch2 for Remote Monitoring in Detecting Atrial Fibrillation in Patient who Need External ECG Monitoring

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009240
Enrollment
100
Registered
2024-03-11
Start date
2024-03-21
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : The treatment is to attach MEMO Patch2 and MEMO Gateway after training on how to use them, monitor with them for 14 days, return them to the site by mail, and check the results. The c

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Participant aged 19 years or older at the time of informed consent who voluntarily agrees to participate, and signs informed consent form in the study 2) Participant who need external ECG monitoring

Exclusion criteria

Exclusion criteria: 1) Participant who are not suitable for the study or may increase risk because determined by the investigator 2) Participant with skin diseases such as sensitive or allergic skin, skin cancer, rash etc. 3) Participant with pacemaker, implantable cardioverter defibrillator (ICD) or another implantable electrical device. 4) Participant who is judged to have difficulty understanding information about the meaning and making decision voluntarily due to cognitive vulnerability. 5) Participant who are determined by the investigator to be inappropriate for participation in the study because it may affect the results of the study or ethically.

Design outcomes

Primary

MeasureTime frame
The detection rate of atrial Fibrillation

Secondary

MeasureTime frame
Accuracy of atrial fibrillation remote alarm (%);Early diagnostic date of atrial fibrillation via remote alarm;Major arrhythmia detection rate excluding atrial fibrillation;Arrhythmia detection rate by attachment date with MEMO Patch2;The evaluation of usability

Countries

Korea, Republic of

Contacts

Public ContactMyoungEun Kim

Asan Medical Center

kme0907asan@gmail.com+82-2-3010-1586

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026