Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia

Not Applicable

Recruiting

• Conditions: Arrhythmia

• Registration Number: NCT06250712
• Lead Sponsor: Wonju Severance Christian Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-09
• Study Start: 2024-02-22
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-24
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 588

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diagnostic yield	1 month	(Number of patient with triggered event without arrhythmia + Number of patients with clnically significant arrhytmia) / total patients

Secondary Outcome Measures

Name	Time	Method
Arrhythmia detection rate	3 month	Compare the arrhythmia diagnosis rate between the two devices.
Cost-effectiveness	3 month	Compare Total medical cost incurred for arrhythmia symptoms between the two devices
Chagne of Quality of Life	Baseline, 3 month	Compare Quality Of Life using Euro QOL-5D-5L between the two devices
User convenience	3 month	Comparison of User convenience using questionnaires in patients who used both devices (ease, portability, satisfaction, etc.) The questionnaire consists of 5 scales from 1 to 5

Trial Locations

Locations (1)

Wonju Severance Christian Hospital; 🇰🇷 Wonju, Gangwon-do, Korea, Republic of