Arrhythmia Detection With MEMO Patch Plus in Patients With Acute Heart Failure

NCT07792772 | Completed

• 1 other identifier: MMPP-HF
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Acute Heart Failure (AHF); Cardiac Arrhythmia

Keywords

MEMO Patch Plus; Extended Electrocardiographic Monitoring; Continuous ECG Monitoring; Wearable ECG Patch; Significant Arrhythmia; Arrhythmia Detection; Atrial Fibrillation; Atrial Flutter; Ventricular Tachycardia; Ambulatory Electrocardiography

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Clinically Significant Arrhythmias Detected by MEMO Patch Plus

  The number and percentage of participants with at least one clinically significant arrhythmia detected during extended electrocardiographic monitoring with MEMO Patch Plus will be assessed. Clinically significant arrhythmias are defined as: * A pause lasting 3 seconds or longer * High-degree atrioventricular block or complete atrioventricular block * Atrial fibrillation or atrial flutter * Supraventricular tachycardia, including atrial tachycardia and paroxysmal supraventricular tachycardia * Ventricular tachycardia * Ventricular fibrillation The number and percentage of participants with each type of clinically significant arrhythmia will also be summarized.

  During inpatient monitoring for up to 14 days and post-discharge monitoring for up to 14 days

Secondary Outcomes (7)

• Percentage of Participants With Other Arrhythmias Detected by MEMO Patch Plus

  From the first MEMO Patch Plus application through 12 weeks after discharge

• Percentage of Participants With Changes in Clinical Management Following an Arrhythmia Diagnosis

  From the first MEMO Patch Plus application through 12 weeks after discharge

• Number and Percentage of Participants With Major Clinical Events

  From discharge through 12 weeks after discharge

• Atrial Fibrillation or Atrial Flutter Burden

  During inpatient monitoring for up to 14 days and post-discharge monitoring for up to 14 days

• Duration of the Longest Atrial Fibrillation or Atrial Flutter Episode

  During inpatient monitoring for up to 14 days and post-discharge monitoring for up to 14 days

Other Outcomes (1)

• Number and Percentage of Participants With Device-Related Adverse Events

  From the first MEMO Patch Plus application through 12 weeks after discharge

Study Arms (1)

MEMO Patch Plus Monitoring Group

EXPERIMENTAL

Participants hospitalized with acute heart failure receive extended electrocardiographic monitoring with MEMO Patch Plus. Participants wear MEMO Patch Plus during hospitalization for up to 14 days and return the device by Visit 2, no later than Day 15. At discharge, participants receive another MEMO Patch Plus device and wear it for up to 14 additional days in the outpatient setting. The post-discharge device is returned by mail. Participants review the complete monitoring results at approximately 6 weeks after discharge and complete a final follow-up assessment at approximately 12 weeks after discharge.

Device: MEMO Patch Plus

Interventions

MEMO Patch Plus DEVICE

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.

MEMO Patch Plus Monitoring Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participant aged 19 years or older
• Participant who voluntarily agrees to participate in the clinical trial and provides written informed consent
• Participant who is hospitalized for acute heart failure
• Acute heart failure is defined as worsening signs or symptoms of heart failure requiring an unplanned hospital admission or emergency department visit.

You may not qualify if:

• Participant who is unable to make a voluntary decision regarding participation in the clinical trial
• Participant who is currently admitted to an intensive care unit
• Participant diagnosed with any of the following clinically significant arrhythmias on the initial standard 12-lead electrocardiogram obtained after presentation:
• A pause lasting 3 seconds or longer
• High-degree atrioventricular block or complete atrioventricular block
• Atrial fibrillation or atrial flutter
• Supraventricular tachycardia, including atrial tachycardia and paroxysmal supraventricular tachycardia
• Ventricular tachycardia
• Ventricular fibrillation
• Participant with a psychiatric disorder, including cognitive impairment or dementia, or a social circumstance that, in the investigator's judgment, may interfere with compliance with the clinical trial
• Participant with a history of an allergic skin reaction to external medical electrodes or equivalent materials
• Participant with a life expectancy of less than 3 months, as determined by the investigator

Sponsors & Collaborators

• HUINNO Co., Ltd: lead
• Asan Medical Center: collaborator
• Korea University Anam Hospital: collaborator
• Seoul National University Bundang Hospital: collaborator

Study Sites (3)

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 28, 2026
• Study Start: July 11, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: August 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)