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Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia

NCT ID: NCT06250712

Last Updated: 2025-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

588 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-22

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Arrhythmia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In the 588 patients who require additional testing due to arrhythmia symptoms, continuous single lead ECG or intermittent handheld ECG will be randomly assigned to the test for 1 month. If arrhythmia symptoms are not diagnosed after 1 month, cross over the device and use it for another month for evaluation.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Continous ECG Patch

In this arm, continuous patch ECG was used.

Group Type EXPERIMENTAL

Continous ECG Patch

Intervention Type DEVICE

Using a continuous patch ECG for 1 week during 1 month

Intermittent handheld ECG

In this arm, intermittent handheld ECG was used.

Group Type ACTIVE_COMPARATOR

Intermittent handheld ECG

Intervention Type DEVICE

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

Interventions

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Continous ECG Patch

Using a continuous patch ECG for 1 week during 1 month

Intervention Type DEVICE

Intermittent handheld ECG

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wonju Severance Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Young Jun Park

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young Jun Park, MD

Role: PRINCIPAL_INVESTIGATOR

Wonju Severance Christian Hopsital

Locations

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Chonnam National University Hospital

Gwangju, Dong-gu Jaebongro 42, South Korea

Site Status RECRUITING

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Site Status RECRUITING

Hallym University Dongtan Sacred Heart Hospital

Gyeonggi-do, Hwaseong-si Keunjaebong-gil 7, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Young Jun Park, MD

Role: CONTACT

[email protected]
82-33-741-0917

Facility Contacts

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Ki hong Lee Professor of division of cardiology, MD

Role: primary

[email protected]
82 01-9962-5830

Young Jun Park

Role: primary

[email protected]

Seong Woo Han Professor, MD

Role: primary

[email protected]
82 01-2630-6489

References

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Raviele A, Giada F, Bergfeldt L, Blanc JJ, Blomstrom-Lundqvist C, Mont L, Morgan JM, Raatikainen MJ, Steinbeck G, Viskin S, Kirchhof P, Braunschweig F, Borggrefe M, Hocini M, Della Bella P, Shah DC; European Heart Rhythm Association. Management of patients with palpitations: a position paper from the European Heart Rhythm Association. Europace. 2011 Jul;13(7):920-34. doi: 10.1093/europace/eur130. No abstract available.

Reference Type BACKGROUND
PMID: 21697315 (View on PubMed)

Turnbull S, Garikapati K, Bennett RG, Campbell TG, Kotake Y, Mahajan R, Marschner S, Byth K, Chow CK, Kumar S. Utility of a Handheld, Single-Lead ECG Device for Diagnosis of Cardiac Arrhythmias. J Am Coll Cardiol. 2023 Jun 13;81(23):2292-2294. doi: 10.1016/j.jacc.2023.03.428. No abstract available.

Reference Type BACKGROUND
PMID: 37286259 (View on PubMed)

Schreiber D, Sattar A, Drigalla D, Higgins S. Ambulatory cardiac monitoring for discharged emergency department patients with possible cardiac arrhythmias. West J Emerg Med. 2014 Mar;15(2):194-8. doi: 10.5811/westjem.2013.11.18973.

Reference Type BACKGROUND
PMID: 24672611 (View on PubMed)

Other Identifiers

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CR223024

Identifier Type: -

Identifier Source: org_study_id

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