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

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection rate of clinically significant arrhythmia* *Clinically significant arrhythmia is defined as follows. 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

Secondary Outcome Measures

Name	Time	Method
1) Detection rate for other arrhythmia items identified through ECG monitoring results 2) The percentage of change in the type of clinical care according to arrhythmia diagnosis A. The percentage of anticoagulant usage/change B. The percentage of antiarrhythmic agent usage/change C. The percentage of conducting DC cardioversion D. The percentage of implantation of cardiac implantable electronic device(pacemaker, ICD, CRT etc) 3) Number and incidence of major clinical events (death, myocardial infarction, cerebral infarction, intensive care unit admission rate, re-admission after discharge) up to 3 months after discharge 4) Burden of atrial fibrillation or atrial flutter 5) The Longest duration of AF/AFL event 6) The Compliance with MEMO Patch Plus A. MEMO Patch Plus actual attached time B. Percentage of electrocardiogram that can be checked