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
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0009240
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 100
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
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The detection rate of atrial Fibrillation
- Secondary Outcome Measures
Name Time Method 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