An interventional study of MEMO Patch Plus in Acute Heart Failure (AHF) and Cardiac Arrhythmia, sponsored by HUINNO Co., Ltd. Completed at 3 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by HUINNO Co., Ltd · Not applicable, Interventional, and Diagnostic
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.
Background
Clinically significant arrhythmias frequently coexist with acute heart failure and may contribute to hemodynamic instability, worsening heart failure, stroke, cardiac arrest, intensive care unit admission, and death. Although continuous electrocardiographic monitoring may allow earlier detection of arrhythmias, evidence regarding the appropriate method and duration of monitoring in patients with acute heart failure who are not receiving intensive care remains limited.
MEMO Patch Plus is a wearable patch-type electrocardiographic monitoring device that continuously records electrocardiographic signals for up to 14 days. This study is designed to evaluate the feasibility and clinical effectiveness of extended electrocardiographic monitoring using MEMO Patch Plus in patients hospitalized with acute heart failure.
Study Design and Population
This is a prospective, multicenter, open-label, single-group exploratory clinical trial. Approximately 46 male and female participants aged 19 years or older who are hospitalized for acute heart failure will be enrolled.
Acute heart failure is defined as worsening signs or symptoms of heart failure requiring an unplanned hospital admission or emergency department visit. Participants with a clinically significant arrhythmia identified on the initial standard 12-lead electrocardiogram are excluded because the study is intended to evaluate newly detected arrhythmias during extended monitoring.
Study Procedures
After written informed consent and confirmation of eligibility, participants are assigned MEMO Patch Plus on Day 1. The device is worn during hospitalization for up to 14 days and is returned to the investigator by Visit 2, which occurs 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 attend Visit 3 approximately 6 weeks after discharge to review the complete electrocardiographic monitoring results. At approximately 12 weeks after discharge, a final follow-up assessment is conducted by telephone to evaluate the participant's clinical course. Adverse events are monitored from the initial device application through the end of study participation.
Clinically Significant Arrhythmias
Clinically significant arrhythmias are defined as one or more of the following:
Outcome Assessments
The primary outcome is the detection rate of clinically significant arrhythmias during MEMO Patch Plus monitoring, presented as the number and proportion of participants with each qualifying arrhythmia.
Secondary assessments include:
Safety is evaluated based on adverse events considered potentially related to MEMO Patch Plus, including their frequency, type, severity, and relationship to the device.
1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.
This study's enrollment of 45 is below the median of 100 across 517 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →HUINNO Co., Ltd is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Acute heart failure is defined as worsening signs or symptoms of heart failure requiring an unplanned hospital admission or emergency department visit.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Time frame: During inpatient monitoring for up to 14 days and post-discharge monitoring for up to 14 days
Percentage of Participants With Other Arrhythmias Detected by MEMO Patch Plus
The number and percentage of participants with arrhythmias other than the prespecified clinically significant arrhythmias detected during MEMO Patch Plus electrocardiographic monitoring will be summarized by arrhythmia type.
Time frame: From the first MEMO Patch Plus application through 12 weeks after discharge
Percentage of Participants With Changes in Clinical Management Following an Arrhythmia Diagnosis
The number and percentage of participants with a change in clinical management resulting from an arrhythmia diagnosis will be summarized for each of the following categories: * Initiation or modification of anticoagulant therapy * Initiation or modification of antiarrhythmic therapy * Direct-current cardioversion * Implantation of a cardiac implantable electronic device, including a pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy device
Time frame: From the first MEMO Patch Plus application through 12 weeks after discharge
Number and Percentage of Participants With Major Clinical Events
The number and percentage of participants experiencing each of the following major clinical events after discharge will be summarized: * Death * Myocardial infarction * Cerebral infarction * Intensive care unit admission * Rehospitalization
Time frame: From discharge through 12 weeks after discharge
Atrial Fibrillation or Atrial Flutter Burden
Among participants in whom atrial fibrillation or atrial flutter is detected, atrial fibrillation or atrial flutter burden will be calculated as the percentage of analyzable electrocardiographic monitoring time spent in atrial fibrillation or atrial flutter.
Time frame: 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
Among participants in whom atrial fibrillation or atrial flutter is detected, the duration of the longest atrial fibrillation or atrial flutter episode identified during MEMO Patch Plus monitoring will be summarized.
Time frame: During inpatient monitoring for up to 14 days and post-discharge monitoring for up to 14 days
Actual Wear Time of MEMO Patch Plus After Discharge
The actual wear time of MEMO Patch Plus used after discharge will be assessed using the total analyzable electrocardiographic recording time. The result will be summarized using descriptive statistics, including the mean, standard deviation, median, minimum, and maximum.
Time frame: During post-discharge monitoring for up to 14 days
Percentage of Interpretable Electrocardiographic Recording
The percentage of interpretable electrocardiographic recording obtained from MEMO Patch Plus after discharge will be calculated as: \[(Analyzable recording time - Total noise signal time) / Analyzable recording time\] × 100 The result will be summarized using descriptive statistics, including the mean, standard deviation, median, minimum, and maximum.
Time frame: During post-discharge monitoring for up to 14 days
Number and Percentage of Participants With Device-Related Adverse Events
Adverse events considered to have a possible causal relationship with MEMO Patch Plus will be assessed. The number and percentage of participants with device-related adverse events will be summarized according to event type and severity.
Time frame: From the first MEMO Patch Plus application through 12 weeks after discharge
Plan to share: No
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