An interventional study of Memo Patch continuous ECG and Hativ handheld ECG in Arrhythmia, sponsored by Wonju Severance Christian Hospital. Recruiting at 4 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Wonju Severance Christian Hospital · Not applicable, Interventional, and Diagnostic
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.
HELP-A is an investigator-initiated, prospective, randomized, open-label, multicenter comparative-effectiveness trial conducted at four tertiary hospitals in South Korea. The study evaluates two ambulatory ECG monitoring strategies in adults with palpitations or dizziness that are not explained by a presenting 12-lead ECG and for whom additional ambulatory rhythm monitoring is clinically indicated.
Participants are randomized in a 1:1 ratio, stratified by participating center, to one of two monitoring strategies. Participants assigned to Hativ use a handheld ECG device that provides 10-second 6-lead ECG recordings. They are instructed to record at least twice daily and whenever symptoms occur for 30 days. Participants assigned to Memo Patch undergo continuous single-lead ECG monitoring for up to 7 consecutive days and report symptom onset using a mobile messaging chatbot or paper diary. For each reported symptom, a 20-minute ECG segment from 10 minutes before to 10 minutes after the reported onset is available for review.
The primary endpoint is clinically informative symptom-rhythm correlation established with the initially assigned device by the 1-month follow-up visit. A positive correlation requires an interpretable ECG obtained during a participant-confirmed typical symptomatic episode with a rhythm finding judged 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. Both positive and negative-only correlations count as primary-endpoint success.
Because the assigned monitoring durations differ, a prespecified key secondary analysis re-ascertains the primary endpoint using only data from the first 7 days after randomization, representing the common planned 7-day monitoring window. Clinically significant arrhythmia is evaluated separately from symptom-rhythm correlation and is adjudicated centrally using prespecified device-specific operational definitions.
After completion of the 1-month primary endpoint assessment, participants with persistent symptoms and no clinically informative symptom-rhythm correlation may undergo optional sequential monitoring with the alternative device if further monitoring remains clinically appropriate and the participant agrees. Data obtained during sequential monitoring do not contribute to the primary randomized comparison and are analyzed as exploratory outcomes.
All randomized participants are followed through 3 months. Follow-up includes arrhythmia-directed therapeutic interventions, clinical events, healthcare resource utilization and costs, adverse events, and selected patient-reported outcomes.
1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.
This study's planned enrollment of 588 is above the median of 100 across 517 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Wonju Severance Christian Hospital is the lead sponsor of 43 studies on the registry; 13 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants undergo continuous single-lead ECG monitoring with Memo Patch for up to 7 consecutive days and report symptom onset using a mobile messaging chatbot or paper diary.
Device: Memo Patch continuous ECG
Participants use Hativ for 30 days and perform 10-second 6-lead ECG recordings at least twice daily and whenever symptoms occur.
Device: Hativ handheld 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.
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.
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 visit
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 visit
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 visit
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 visit
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 visit
Arrhythmia-directed therapeutic intervention
Rate and timing of arrhythmia-directed therapeutic interventions, including medication, catheter ablation, or cardiac device implantation.
Time frame: Through 3 months after randomization
Overall satisfaction
Overall satisfaction with the initially assigned device is assessed using the Study-Specific Overall Device Satisfaction Rating, a single-item, five-point ordinal scale in the 1-month participant questionnaire. Responses are scored as 1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, and 5 = very satisfied. The minimum possible score is 1 and the maximum is 5, with higher scores indicating greater satisfaction, a more favorable outcome. The item is assessed separately from device-specific usability questions and willingness to recommend the device.
Time frame: 1-month follow-up visit
EQ-5D-5L
Change in the EQ-5D-5L index score from enrollment to the 1-month follow-up visit.
Time frame: Baseline to 1 month
Healthcare resource utilization and costs
Arrhythmia-related healthcare resource use through 3 months, including additional diagnostic tests, arrhythmia-related medications, emergency department visits, and hospitalizations. Costs are derived from institutional billing records at participating centers and expressed in Korean won. The base-case analysis excludes acquisition cost of the study devices because the devices were supplied in kind.
Time frame: Through 3 months after randomization
Number and Percentage of Participants With Device-Related Adverse Events or Serious Adverse Events
Number and percentage of participants who experience at least one device-related adverse event or at least one serious adverse event through 3 months after randomization. Expected device-related adverse events include skin irritation or contact dermatitis associated with the adhesive patch and discomfort associated with device use. Serious adverse events are included regardless of their relationship to the study device. Each participant is counted once for this outcome, irrespective of the number of qualifying events experienced
Time frame: Through 3 months after randomization
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-up
Plan to share: Yes — De-identified individual participant data underlying the primary publication, together with a data dictionary, will be available from the corresponding investigator on reasonable request after completion of the study and publication of the primary results, subject to ethics approval and execution of an appropriate data-use agreement.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Wonju Severance Christian Hospital