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Arrhythmia Detection With MEMO Patch Plus in Patients With Acute Heart Failure
Sponsor: HUINNO Co., Ltd
Summary
This prospective, multicenter, open-label, single-group exploratory clinical trial evaluates the clinical effectiveness of extended electrocardiographic monitoring with MEMO Patch Plus for detecting clinically significant arrhythmias in adult patients hospitalized with acute heart failure. Eligible participants receive continuous electrocardiographic monitoring with MEMO Patch Plus for up to 14 days during hospitalization and again for up to 14 days after discharge. Participants return the post-discharge device by mail, review the monitoring results approximately 6 weeks after discharge, and complete a final follow-up assessment approximately 12 weeks after discharge. The primary outcome is the proportion of participants in whom a clinically significant arrhythmia is detected. Secondary outcomes include the detection of other arrhythmias, changes in clinical management following an arrhythmia diagnosis, major clinical events through 3 months after discharge, atrial fibrillation or atrial flutter burden, the longest atrial fibrillation or atrial flutter episode, and adherence to MEMO Patch Plus monitoring.
Official title: 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
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2023-07-11
Completion Date
2026-04-30
Last Updated
2026-08-28
Healthy Volunteers
No
Interventions
MEMO Patch Plus
MEMO Patch Plus is a wearable, noninvasive electrocardiographic monitoring device designed for long-term recording and reproduction of electrocardiographic signals. In this study, eligible participants receive MEMO Patch Plus on Day 1 and wear the device during hospitalization for up to 14 days. At discharge, participants receive another MEMO Patch Plus device and wear it for up to 14 additional days after discharge. The device records electrocardiographic data for the detection of clinically significant and other arrhythmias. Clinically significant arrhythmias include a pause lasting 3 seconds or longer, high-degree or complete atrioventricular block, atrial fibrillation or atrial flutter, supraventricular tachycardia, ventricular tachycardia, and ventricular fibrillation.
Locations (3)
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
Asan Medical Center
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea