Hativ® ELectrocardiogram Monitoring on Patients With Suspected 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

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.

Conditions2

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