A Multi-Center, Prospective, Open Label Clinical Trial to Evaluate Impact of Extended Electrocardiographic Monitoring Using MEMO Patch Plus in Patients with Acute Heart Failure

Asan Medical Center0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年8月19日

适应症

试验速览

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•1) Male or female adults aged 19 years or older at the time of informed consent
•2) Participant who voluntarily agrees to participate and signs informed consent form in the study
•3) Participant with Acute Heart Failure who is hospitalized*
•* It is defined as hospitalization or visiting ER (Emergency Room) due to worsening symptoms and signs of Heart Failure

•Any potential participant who meets any of the following criteria will be excluded from participating in the study.
•1) Participant who does not have the ability to voluntarily decide on their decision to participate in the study
•2) Participate who is admitted to ICU (Intensive Care Unit)
•3) Participate diagnosed with the following the main type of arrhythmia on standard 12-lead ECG evaluated for the first time after visiting the hospital
•*Clinically Significant Arrhythmia is defined by the following items.
•A. Pause lasting more than 3 seconds
•B. High-degree AV Block or Complete AV Block
•C. Atrial fibrillation/flutter
•D. Supraventricular tachycardia(including atrial tachycardia and paroxysmal ventricular tachycardia)
•E. Ventricular tachycardia
•F. Ventricular fibrillation
•4) Subject with a mental illness (cognitive disorder or dementia, etc.) judged by the investigator to interrupt with the compliance of the study or who is in social situation
•5) Subject who has experienced allergic skin trouble to extracorporeal medical electrodes and the same preparations
•6) Subject with life expectancy less than 3 months as determined by the investigator

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