NCT06250712

Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 588 (estimated)
• Sponsor: Wonju Severance Christian Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

HELP-A study is a single-center, randomized, controlled trial. A total of 588 patients enrolled during the 2 years of enrollment period and followed for 1 month of follow-up period. This study aims to compare diagnostic yield between continuous ECG Patch and intermittent handheld ECG in patients with arrhythmia symptoms.

Detailed description

HELP-A study is a single-center, randomized, controlled trial designed to compare diagnostic yield, arrhythmia detection rate, user convenience, and cost-effectiveness between continuous ECG Patch and intermittent handheld ECG in patients with arrhythmia symptoms. Patients who have symptoms of arrhythmia but are not diagnosed on a 12-lead ECG and require additional tests. A total of 588 patients enrolled during the 2 years of enrollment period and followed for 3 month of follow-up period. Patients will be assigned to continuous patch ECG or intermittent handheld ECG and will be examined for one month. If there is no diagnosis after a month, the patient will be crossed over to another device and examined for another month.

Conditions

• Arrhythmia

Interventions

Type	Name	Description
DEVICE	Continous ECG Patch	Using a continuous patch ECG for 1 week during 1 month
DEVICE	Intermittent handheld ECG	Using a handheld ECG twice daily and when symptoms are present during 1 month

Timeline

• Start date: 2024-02-22
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-02-09
• Last updated: 2025-09-26

Locations

3 sites across 1 country: South Korea