Monitoring heart rhythms in patients with suspected arrhythmia
Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia
NA · Wonju Severance Christian Hospital · NCT06250712
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 588 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Wonju Severance Christian Hospital (other) |
| Locations | 3 sites (Gwangju, Dong-gu Jaebongro 42 and 2 other locations) |
| Trial ID | NCT06250712 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with cardiac implantable electronic devices or those unable to use handheld ECG devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy for patients experiencing arrhythmia symptoms.
How similar studies have performed: Other studies have shown promise in using continuous ECG monitoring for arrhythmia detection, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who have arrhythmia symptoms but are not diagnosed on a 12-lead electrocardiogram and require additional tests. * Patients who can use a smartphone Exclusion Criteria: * Patients who have cardiac implantable electronic devices(CIEDs) * Patients who can't use handheld ECG
Where this trial is running
Gwangju, Dong-gu Jaebongro 42 and 2 other locations
- 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)
Study contacts
- Principal investigator: Young Jun Park, MD — Wonju Severance Christian Hopsital
- Study coordinator: Young Jun Park, MD
- Email: pyj@yonsei.ac.kr
- Phone: 82-33-741-0917
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Arrhythmia, Palpitation, Dizziness