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Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia
Sponsor: Wonju Severance Christian Hospital
Summary
HELP-A is a prospective, randomized, open-label, multicenter comparative-effectiveness trial comparing two ambulatory electrocardiographic monitoring strategies in adults with palpitations or dizziness and a nondiagnostic 12-lead ECG. A total of 588 participants are randomized 1:1 to 30-day intermittent handheld 6-lead ECG monitoring (Hativ) or up to 7 days of continuous single-lead patch ECG monitoring (Memo Patch). The primary endpoint is clinically informative symptom-rhythm correlation established with the initially assigned device by the 1-month follow-up visit. Participants without a symptom-rhythm correlation who remain symptomatic may undergo optional sequential monitoring with the alternative device after primary endpoint ascertainment. Clinical outcomes, arrhythmia-directed interventions, healthcare resource utilization, costs, and adverse events are assessed through 3 months.
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
588
Start Date
2024-02-22
Completion Date
2027-06-30
Last Updated
2026-10-05
Healthy Volunteers
No
Conditions
Interventions
Memo Patch continuous ECG
Continuous single-lead ECG monitoring for up to 7 consecutive days. Participants report the onset of symptoms using a mobile messaging chatbot or paper diary. For each reported symptomatic episode, a 20-minute ECG segment extending from 10 minutes before to 10 minutes after the reported onset is available for review.
Hativ handheld ECG
Handheld ECG monitoring using 10-second 6-lead recordings obtained at least twice daily and additionally whenever symptoms occur for 30 days. Recordings are transmitted through the companion smartphone application to a secure study server.
Locations (4)
Chonnam National University Hospital
Gwangju, Dong-gu Jaebongro 42, South Korea
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea
Hallym University Dongtan Sacred Heart Hospital
Gyeonggi-do, Hwaseong-si Keunjaebong-gil 7, South Korea
Korea University Anam Hospital
Seoul, Seongbuk-gu, 73 Goryeodae-ro, South Korea