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Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia

Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia

Recruiting
19 years and older
All
Phase N/A

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Overview

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.

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.

Eligibility

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 details
    Arrhythmia

NCT06250712

Wonju Severance Christian Hospital

4 May 2024

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