This Exploratory Medical Device Study Evaluated the Arrhythmia Diagnostic Yield of MEMO Patch V2, a Wearable Patch-type Electrocardiographic Monitor, in Adults With Suspected Arrhythmia Who Presented With Symptoms Such as Palpitations or Dizziness, or Who Had Cryptogenic Ischemic Stroke or Transient

N/ACompletedNCT07722026

HUINNO Co., Ltd150 enrolled

Overview

This exploratory medical device study evaluated the arrhythmia diagnostic yield of MEMO Patch V2, a wearable patch-type electrocardiographic monitor, in adults with suspected arrhythmia who presented with symptoms such as palpitations or dizziness, or who had cryptogenic ischemic stroke or transient ischemic attack. The diagnostic yield of MEMO Patch V2 was compared with that of conventional 24-hour ambulatory electrocardiography (Holter monitoring). The study also assessed ECG signal quality, participant compliance, usability and satisfaction, and skin-related adverse events. The findings were intended to provide preliminary data for planning a future large-scale clinical study.

This was a multicenter, non-randomized, controlled, open-label pilot clinical trial conducted at Korea University Anam Hospital and Seoul National University Bundang Hospital. Adults aged 19 to 80 years who required ECG monitoring because of suspected arrhythmia associated with palpitations or dizziness, or because of cryptogenic ischemic stroke or transient ischemic attack, were eligible. All participants underwent simultaneous application of a conventional 24-hour Holter monitor and MEMO Patch V2 on Day 0. The Holter monitor was removed and returned on Day 1, while MEMO Patch V2 continuously recorded a single-channel ECG for up to 14 days and was returned by courier. Participants attended an end-of-study visit on Day 21 ± 3 days. Effectiveness was evaluated by comparing arrhythmia detection rates and by assessing ECG signal quality, participant compliance, and device usability and satisfaction. Safety was evaluated based on skin-related adverse events occurring at the application site. A total of 150 participants were enrolled; the Full Analysis Set included 147 participants, the Per-Protocol Set included 141 participants, and the Safety Set included 150 participants.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Interventions

MEMO Patch V2DEVICE

MEMO Patch V2 is a wearable, single-channel patch-type ECG monitoring device intended for long-term ambulatory ECG recording. The device was applied on Day 0 and used for continuous ECG monitoring for up to 14 days. ECG data were stored and transferred for review through the MEMO ECG Webviewer. Electrode patches were replaced every 24 hours, and the device was returned by courier after monitoring.

24-Hour Holter MonitorDEVICE

A conventional ambulatory electrocardiographic monitor was applied simultaneously with MEMO Patch V2 on Day 0 and used for continuous ECG recording for approximately 24 hours. The device was removed and returned at the clinical site on Day 1.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adults aged 19 to 80 years. 2. Participants who required ECG monitoring because of suspected arrhythmia associated with symptoms such as palpitations or dizziness; or participants with cryptogenic ischemic stroke or transient ischemic attack. 3. Participants able to wear MEMO Patch V2 for 14 days. 4. Participants who received a detailed explanation of the study, fully understood it, and voluntarily provided written informed consent. Exclusion Criteria: 1. History of allergic reactions to adhesive products. 2. Participants who required inpatient management during the study because of atrial fibrillation, stroke, transient ischemic attack, another clinically significant condition as determined by the investigator, or a history of dehydration or syncope within 1 year before screening. 3. Any other condition that, in the investigator's judgment, made the participant unsuitable for study participation.

Outcomes

Primary Outcomes

Arrhythmia Detection Rate (%)

The proportion of participants diagnosed with at least one arrhythmia using MEMO Patch V2 was compared with the proportion diagnosed using the 24-hour Holter monitor. Arrhythmias included premature atrial contraction, premature ventricular contraction, atrial tachycardia, atrial flutter, atrial fibrillation, paroxysmal supraventricular tachycardia, ventricular tachycardia, second- or third-degree atrioventricular block, sinus pause, and other arrhythmias. Comparisons included the total monitoring periods (Holter: 24 hours; MEMO Patch V2: at least 7 days) and the first 24 hours for both devices.

Time frame: From device application on Day 0 through completion of MEMO Patch V2 monitoring, up to 14 days

Secondary Outcomes

ECG Signal Quality

The percentage of analyzable MEMO Patch V2 recording time after excluding noise signals.

Time frame: Up to 14 days

Participant Compliance

Compliance was calculated as actual wear time, excluding lead-off time, divided by the required total wear time of 336 hours, multiplied by 100.

Time frame: Up to 14 days

Usability and Satisfaction

A 10-item questionnaire was scored on a 5-point scale and converted to a total score ranging from 0 to 100.

Time frame: Day 21 ± 3 days