Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia

NCT06250712 | Recruiting

• 1 other identifier: CR223024
• Study Type: interventional
• Target: 588
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Arrhythmia

Keywords

Palpitation; Dizziness; Arrhythmia

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield

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

  1 month

Secondary Outcomes (4)

• Arrhythmia detection rate

  3 month

• Cost-effectiveness

  3 month

• Chagne of Quality of Life

  Baseline, 3 month

• User convenience

  3 month

Study Arms (2)

Continous ECG Patch

EXPERIMENTAL

In this arm, continuous patch ECG was used.

Device: Continous ECG Patch

Intermittent handheld ECG

ACTIVE COMPARATOR

In this arm, intermittent handheld ECG was used.

Device: Intermittent handheld ECG

Interventions

Continous ECG Patch DEVICE

Using a continuous patch ECG for 1 week during 1 month

Continous ECG Patch

Intermittent handheld ECG DEVICE

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

Intermittent handheld ECG

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have arrhythmia symptoms but are not diagnosed on a 12-lead electrocardiogram and require additional tests.
• Patients who can use a smartphone

You may not qualify if:

• Patients who have cardiac implantable electronic devices(CIEDs)
• Patients who can't use handheld ECG

Sponsors & Collaborators

• Wonju Severance Christian Hospital: lead

Study Sites (3)

Chonnam National University Hospital

Gwangju, Dong-gu Jaebongro 42, 61469, South Korea

RECRUITING

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

RECRUITING

Hallym University Dongtan Sacred Heart Hospital

Gyeonggi-do, Hwaseong-si Keunjaebong-gil 7, 18450, South Korea

RECRUITING

Related Publications (3)

• 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.

  PMID: 21697315 BACKGROUND

• 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.

  PMID: 37286259 BACKGROUND

• 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.

  PMID: 24672611 BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac; Dizziness

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Young Jun Park, MD

  Wonju Severance Christian Hopsital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Young Jun Park, MD

CONTACT

82-33-741-0917; pyj@yonsei.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 9, 2024
• Study Start: February 22, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-08

Locations

KR (3)