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NCT Number: NCT06250712

Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia

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.

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Key information

Conditions

Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Dizziness Heart Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chonnam National University Hospital, Gwangju, Dong-gu Jaebongro 42, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continous ECG Patch

Device

Using a continuous patch ECG for 1 week during 1 month

Intermittent handheld ECG

Device

Using a handheld ECG twice daily and when symptoms are present during 1 month

Primary outcomes

  1. Diagnostic yield

    Time frame: 1 month

    (Number of patient with triggered event without arrhythmia + Number of patients with clnically significant arrhytmia) / total patients

Secondary outcomes

  1. Arrhythmia detection rate

    Time frame: 3 month

    Compare the arrhythmia diagnosis rate between the two devices.

  2. Cost-effectiveness

    Time frame: 3 month

    Compare Total medical cost incurred for arrhythmia symptoms between the two devices

  3. Chagne of Quality of Life

    Time frame: Baseline, 3 month

    Compare Quality Of Life using Euro QOL-5D-5L between the two devices

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Young Park, MD

CONTACT

[email protected]

82-2-920-5445

Sponsors and collaborators

Lead sponsor

Wonju Severance Christian Hospital

Other

Registry information

Acronym: HELP-A

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2024
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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