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Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia

RecruitingNAAges 19 Years - anyAllWonju Severance Christian Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Age 19 years or older. * Palpitations or dizziness not explained by the presenting 12-lead ECG. * A clinical indication for additional ambulatory ECG monitoring. * Ownership of and ability to use a compatible smartphone. * Ability to provide written informed consent and comply with study procedures Exclusion Criteria: * Physical disability or another condition that prevents appropriate use of the handheld ECG device. * Presence of a cardiac implantable electronic device or ventricular assist device. * Inability to read or understand the informed consent document. * Any other condition that, in the investigator's judgment, makes participation in the study inappropriate.
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What it tests

  • Memo Patch continuous ECG
  • Hativ handheld ECG
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Where

4 sites
Chonnam National University Hospital
Gwangju, South Korea
Wonju Severance Christian Hospital
Wŏnju, South Korea
Hallym University Dongtan Sacred Heart Hospital
Gyeonggi-do, South Korea
Korea University Anam Hospital
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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