Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia
ConditionArrhythmia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorWonju Severance Christian Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Memo Patch continuous ECG
DeviceContinuous 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
DeviceHandheld 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.
Treatment groups
588 Participants
are divided into 2 treatment groupsGroup A: Memo Patch continuous ECG strategyExperimental treatment 1 intervention
Group B: Hativ handheld ECG strategyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Clinically informative symptom-rhythm correlation with the initially assigned device by 1 month
Proportion of randomized participants with at least one participant-confirmed typical symptomatic episode documented with an interpretable ECG using the initially assigned device by the 1-month follow-up visit and before optional sequential monitoring. Primary-endpoint success comprises either a positive symptom-rhythm correlation or a negative-only symptom-rhythm correlation. A positive correlation is a qualifying symptomatic episode with an interpretable ECG showing a rhythm finding judged by central adjudication to be temporally and clinically concordant with that episode. A negative-only correlation requires at least one qualifying symptomatic episode with an interpretable ECG showing no concordant rhythm finding and no positive correlation by the 1-month visit.
Time frame
From randomization through the 1-month follow-up visitSecondary outcomes
1
Positive symptom-rhythm correlation
Proportion of participants with at least one qualifying participant-confirmed typical symptomatic episode documented with an interpretable ECG showing a rhythm finding judged by central adjudication to be temporally and clinically concordant with that episode.
Time frame
By the 1-month follow-up visit2
Negative-only symptom-rhythm correlation
Proportion of participants with at least one qualifying participant-confirmed typical symptomatic episode documented with an interpretable ECG showing no temporally and clinically concordant rhythm finding and with no positive correlation by the 1-month follow-up visit.
Time frame
By the 1-month follow-up visit3
Both positive and negative episodes
Proportion of participants with at least one qualifying positive symptom-rhythm correlation and at least one qualifying negative symptom-rhythm correlation. This measure is descriptive.
Time frame
By the 1-month follow-up visit4
Clinically significant arrhythmia detected during assigned-device monitoring
Proportion of participants with at least one centrally adjudicated clinically significant arrhythmia detected during initially assigned-device monitoring, irrespective of symptom association. Clinically significant arrhythmias are classified using prespecified device-specific operational definitions. Findings are additionally classified as symptom-associated or not temporally associated with a qualifying typical symptomatic episode.
Time frame
By the 1-month follow-up visitOther outcomes
1
Sequential-monitoring participant questionnaire
Among participants who undergo optional sequential monitoring with both study devices, paired evaluations are collected using the Study-Specific Three-Month Head-to-Head Device Evaluation Questionnaire. Device usability is assessed separately for each device using eight items. Each item is scored from 1 (very difficult) to 5 (very easy), with 2 = difficult, 3 = neither difficult nor easy, and 4 = easy. The minimum possible score for each item is 1 and the maximum is 5; higher scores indicate better perceived usability. "Not applicable" responses are recorded separately and are not assigned a numerical score. Usability items are reported individually rather than combined into a total score. Overall satisfaction with each device is assessed using a single five-point ordinal item, scored from 1 (very dissatisfied) to 5 (very satisfied), with 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, and 4 = satisfied. The minimum possible score is 1 and the maximum is 5; higher scores i
Time frame
3-month follow-upSponsors and contacts
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Source ClinicalTrials.gov