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

Wonju Severance Christian Hospital

Status: Enrolling

Conditions: Arrhythmia

Treatments: Device: Intermittent handheld ECG; Device: Continous ECG Patch

Study type: Interventional

Funder types: Other

Identifiers

NCT06250712

CR223024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 588 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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588 participants in 2 patient groups

Continous ECG Patch

Experimental group

Description:

In this arm, continuous patch ECG was used.

Treatment:

Device: Continous ECG Patch

Intermittent handheld ECG

Active Comparator group

Description:

In this arm, intermittent handheld ECG was used.

Treatment:

Device: Intermittent handheld ECG