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

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.

Inclusion criteria

• Adults aged 19 to 80 years.
• 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.
• Participants able to wear MEMO Patch V2 for 14 days.
• Participants who received a detailed explanation of the study, fully understood it, and voluntarily provided written informed consent.

Exclusion criteria

• History of allergic reactions to adhesive products.
• 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.
• Any other condition that, in the investigator's judgment, made the participant unsuitable for study participation.