Monitoring heart rhythms in patients with suspected arrhythmia
Official title: Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia
Run by Wonju Severance Christian Hospital · NCT06250712 · Data updated 2026-11-12
This study is testing whether continuous ECG patches work better than handheld ECG devices for diagnosing arrhythmia symptoms in patients who haven't gotten clear results from standard tests.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 588 (estimated) |
| Sponsor | Wonju Severance Christian Hospital Academic / other |
| Locations | 4 sites (Gwangju, Dong-gu Jaebongro 42 and 3 other locations) |
| Status | Recruiting |
| Started | February 22, 2024 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT06250712 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with arrhythmia symptoms who have not been diagnosed through a standard 12-lead ECG and can use a smartphone.
✕Probably not a fit
Patients with cardiac implantable electronic devices or those unable to use handheld ECG devices may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The HELP-A study is a single-center, randomized, controlled trial that aims to compare the effectiveness of continuous ECG patches versus intermittent handheld ECG devices in diagnosing arrhythmia symptoms. A total of 588 patients will be enrolled over two years and followed for one month to assess the diagnostic yield, detection rates, user convenience, and cost-effectiveness of both methods. Patients who exhibit arrhythmia symptoms but have inconclusive results from a standard 12-lead ECG will participate in this study, with the possibility of switching devices if no diagnosis is made within the initial month.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy for patients experiencing arrhythmia symptoms.
How similar studies have gone: Other studies have shown promise in using continuous ECG monitoring for arrhythmia detection, suggesting this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Chonnam National University Hospital
Gwangju, Dong-gu Jaebongro 42, South Korea Recruiting -
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea Recruiting -
Hallym University Dongtan Sacred Heart Hospital
Gyeonggi-do, Hwaseong-si Keunjaebong-gil 7, South Korea Recruiting -
Korea University Anam Hospital
Seoul, Seongbuk-gu, 73 Goryeodae-ro, South Korea Recruiting
Study contacts
- Principal investigator: Young Jun Park, MD — Wonju Severance Christian Hopsital
- Study coordinator: Young Park, MD
- Email: yjparkcardio@gmail.com
- Phone: 82-2-920-5445
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.