Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia (HELP-A)

July 18, 2026 updated by: Young Jun Park, Wonju Severance Christian Hospital
The HELP-A study is a multicenter, randomized, controlled trial. A total of 588 patients were enrolled during the 4-year enrollment period and followed for 1 month. This study aims to compare the diagnostic yield of a continuous ECG patch versus an intermittent handheld ECG in patients with arrhythmia symptoms.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The HELP-A study is a multicenter, randomized, controlled trial designed to compare the diagnostic yield, arrhythmia detection rate, user convenience, and cost-effectiveness of a continuous ECG patch versus an intermittent handheld ECG in patients with arrhythmia symptoms. The study enrolls patients who have symptoms suggestive of arrhythmia but remain undiagnosed on a 12-lead ECG and require additional testing. A total of 588 patients will be enrolled during the 4-year enrollment period and followed for 3 months. Patients will be randomly assigned to either a continuous patch ECG or an intermittent handheld ECG and monitored for one month. If no diagnosis is made after one month, patients will cross over to the other device and be monitored for an additional month.

Study Type

Interventional

Enrollment (Estimated)

588

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Seoul, South Korea
        • Recruiting
        • Korea anam hospital
        • Contact:
    • Dong-gu Jaebongro 42
      • Gwangju, Dong-gu Jaebongro 42, South Korea, 61469
        • Recruiting
        • Chonnam National University Hospital
        • Contact:
    • Gangwon-do
      • Wŏnju, Gangwon-do, South Korea, 26426
    • Hwaseong-si Keunjaebong-gil 7
      • Gyeonggi-do, Hwaseong-si Keunjaebong-gil 7, South Korea, 18450
        • Recruiting
        • Hallym University Dongtan Sacred Heart Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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
  • Patient who had syncope

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Continous ECG Patch
In this arm, continuous patch ECG was used.
Device: Continous ECG Patch
Using a continuous patch ECG for 1 week during 1 month
Active Comparator: Intermittent handheld ECG
In this arm, intermittent handheld ECG was used.
Device: Intermittent handheld ECG
Using a handheld ECG twice daily and when symptoms are present during 1 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic yield
Time Frame: 1 month
(Number of patient with triggered event without arrhythmia + Number of patients with clnically significant arrhytmia) / total patients
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arrhythmia detection rate
Time Frame: 3 month
Compare the arrhythmia diagnosis rate between the two devices.
3 month
Cost-effectiveness
Time Frame: 3 month
Compare Total medical cost incurred for arrhythmia symptoms between the two devices
3 month
Chagne of Quality of Life
Time Frame: Baseline, 3 month
Compare Quality Of Life using Euro QOL-5D-5L between the two devices
Baseline, 3 month
User convenience
Time Frame: 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
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wonju Severance Christian Hospital

Investigators

  • Principal Investigator: Young Jun Park, MD, Wonju Severance Christian Hopsital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 31, 2024

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Actual)

February 9, 2024

Study Record Updates

Last Update Posted (Actual)

July 21, 2026

Last Update Submitted That Met QC Criteria

July 18, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR223024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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