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Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia

Study acronym: HELP-A
StatusRecruiting
PhaseNot applicable
Started2024-02-22
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Wonju Severance Christian Hospital

Amendment history

2026-09-01
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v4
Primary endpoint(s) modified1 entry, revised
WasDiagnostic yield
NowClinically informative symptom-rhythm correlation with the initially assigned device by 1 month
Interventions modified
Eligibility criteria+363 characters
Inclusion Criteria: PatientsAge who19 haveyears arrhythmiaor symptomsolder. Palpitations butor aredizziness not diagnosedexplained onby athe presenting 12-lead electrocardiogramECG. A clinical indication for additional ambulatory ECG monitoring. Ownership of and requireability additional tests. Patients who canto use a compatible smartphone. Ability to provide written informed consent and comply with study procedures Exclusion Criteria: PatientsPhysical whodisability haveor another condition that prevents appropriate use of the handheld ECG device. Presence of a cardiac implantable electronic [...]
Secondary endpoints4 to 9 entries
Positive symptom-rhythm correlation Negative-only symptom-rhythm correlation Both positive and negative episodes Clinically significant arrhythmia detected during assigned-device monitoring Arrhythmia-directed detectiontherapeutic rateintervention CostOverall satisfaction EQ-effectiveness5D-5L ChagneHealthcare ofresource Qualityutilization ofand Lifecosts UserSafety convenienceOutcome
Study description+2,007 characters
The HELP-A study is aan multicenterinvestigator-initiated, prospective, randomized, controlledopen-label, multicenter comparative-effectiveness trial designedconducted toat comparefour thetertiary diagnostic yield, arrhythmia detection rate, user convenience, and cost-effectiveness of a continuous ECG patch versus an intermittent handheld ECGhospitals in patientsSouth with arrhythmia symptomsKorea. The study enrollsevaluates patientstwo whoambulatory haveECG symptomsmonitoring suggestivestrategies ofin arrhythmiaadults butwith remainpalpitations undiagnosedor ondizziness that are not explained [...] [...]
Study sites4 entries, revised
Korea anamUniversity hospitalAnam Hospital
2026-07-18
Study Status, Oversight, Study Description, Eligibility, Contacts/Locations v3
Primary completion date2025-12-31→2026-12-31
Completion date2025-12-31→2026-12-31
Study sites3→4
Eligibility criteria+24 characters
[...] lectronic devices(CIEDs) Patients who can't use handheld ECG Patient who had syncope
Study description+45 characters
The HELP-A study is a single-centermulticenter, randomized, controlled trial designed to compare the diagnostic yield, arrhythmia detection rate, user convenience, and cost-effectiveness betweenof a continuous ECG Patchpatch andversus an intermittent handheld ECG in patients with arrhythmia symptoms. PatientsThe study enrolls patients who have symptoms suggestive of arrhythmia but areremain not diagnosedundiagnosed on a 12-lead ECG and require additional teststesting. A total of 588 patients will be enrolled during the 2 years of4-year enrollment period and followed for 3 month of follow-up pe [...] [...]
2025-09-22
Study Status, Oversight, Contacts/Locations v2
Study sites1→3
2024-04-22
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-03-01→confirmed 2024-02-22
Study sitesdetails revised at 1 of 1 site
2024-02-07
Original filing
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.
Trial Details
NCT Number NCT06250712
Lead Sponsor Wonju Severance Christian Hospital
Conditions Arrhythmia
Enrollment 588 participants
Start Date 2024-02-22
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-04