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

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

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:

• 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

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:

• Detection rates of other arrhythmias identified during electrocardiographic monitoring
• Changes in clinical management resulting from an arrhythmia diagnosis, including initiation or modification of anticoagulant or antiarrhythmic therapy, direct-current cardioversion, and implantation of a cardiac implantable electronic device
• The number and proportion of participants experiencing death, myocardial infarction, cerebral infarction, intensive care unit admission, or rehospitalization through 3 months after discharge
• Atrial fibrillation or atrial flutter burden
• Duration of the longest atrial fibrillation or atrial flutter episode
• MEMO Patch Plus adherence, assessed using actual analyzable wearing time and the proportion of interpretable electrocardiographic data

Safety is evaluated based on adverse events considered potentially related to MEMO Patch Plus, including their frequency, type, severity, and relationship to the device.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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