This Exploratory Medical Device Study Evaluated the Arrhythmia Diagnostic Yield of MEMO Patch V2, a Wearable Patch-type Electrocardiographic... | NCT07722026

NCT07722026

Overview

NCT ID: NCT07722026
Lead Sponsor: HUINNO Co., LtdINDUSTRY
Official Title: A Multicenter, Non-randomized, Controlled, Open-label Pilot Clinical Trial to Compare and Evaluate the Arrhythmia Diagnostic Performance of MEMO Patch V2 and 24-Hour Ambulatory Electrocardiography in Patients With Suspected Arrhythmia Presenting With Palpitations or Dizziness
Brief Summary: 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.
Conditions

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.