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Completed
NCT07728552
7-Day MEMO Patch Monitoring for Arrhythmia Detection in Patients With Palpitations
Conditions: Arrhythmia, Palpitations, Syncope
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: HUINNO Co., Ltd
Location: Seoul National University Bundang Hospital Seoul
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."
Eligibility Criteria
Inclusion Criteria:
* Participants must meet all of the following criteria:
1. 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.
2. Able and willing to provide voluntary written informed consent.
3. Able to wear the MEMO Patch™ continuously for 7 days.
Exclusion Criteria:
* Participants meeting any of the following criteria will be excluded:
1. A self-reported history of an allergic skin reaction to previously used adhesive products.
2. Planned electrical cardioversion, catheter ablation, or surgical treatment for an arrhythmia during the study period.
Source: ClinicalTrials.gov (NCT07728552). StuddyBuddy aggregates publicly available trial information.