RecruitingNot ApplicableNCT06250712

Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia

Sponsor

Wonju Severance Christian Hospital

Enrollment

588 participants

Start Date

Feb 22, 2024

Study Type

INTERVENTIONAL

Conditions

Arrhythmia

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.

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Continous ECG Patch and a medical device called Intermittent handheld ECG for people with arrhythmia. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 19 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMemo 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.

DEVICEHativ 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.