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NCT07728552

Overview

NCT ID: NCT07728552
Lead Sponsor: HUINNO Co., LtdINDUSTRY
Official Title: An Exploratory Study to Evaluate Diagnostic Accuracy of a 7-day Adhesive Patch Electrocardiographic Monitoring for Detecting Arrhythmia in Patients With Palpitation.
Brief Summary: "This exploratory prospective clinical study aims to evaluate the diagnostic yield of a 7-day adhesive electrocardiographic (ECG) monitoring device (MEMO Patch) in detecting cardiac arrhythmias in patients presenting with palpitations.

Participants who require 24-hour Holter monitoring because of symptoms such as palpitations or dizziness will simultaneously wear a conventional 24-hour Holter monitor and the MEMO Patch. The Holter monitor will be removed after 24 hours, while the MEMO Patch will continue monitoring for a total of 7 days. ECG recordings will be evaluated by cardiologists after technical quality assessment. The study will assess arrhythmia detection, device-related skin adverse events, and participant usability and satisfaction."
Conditions

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

Participants must meet all of the following criteria:

Adults aged 19 years or older who visit the study site during the study period with symptoms such as palpitations or syncope and are considered to require 24-hour ambulatory electrocardiographic monitoring.

Able and willing to provide voluntary written informed consent.

Able to wear the MEMO Patch™ continuously for 7 days.

Exclusion Criteria:

Participants meeting any of the following criteria will be excluded:

A self-reported history of an allergic skin reaction to previously used adhesive products.

Planned electrical cardioversion, catheter ablation, or surgical treatment for an arrhythmia during the study period.