Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia

Arrhythmia Clinical Trial

— HELP-A  

Official title:

Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06250712
• Other study ID #: CR223024
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Wonju Severance Christian Hospital
• Contact: Young Jun Park, MD
• Phone: 82-33-741-0917
• Email: pyj[@]yonsei.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 588
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

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

Related Conditions & MeSH terms

• Arrhythmia
• Arrhythmias, Cardiac

Intervention

Device:
• Continous ECG Patch
Using a continuous patch ECG for 1 week during 1 month
• Intermittent handheld ECG
Using a handheld ECG twice daily and when symptoms are present during 1 month

Locations

Country	Name	City	State
Korea, Republic of	Wonju Severance Christian Hospital	Wonju	Gangwon-do

Sponsors (1)

Lead Sponsor	Collaborator
Wonju Severance Christian Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic yield	(Number of patient with triggered event without arrhythmia + Number of patients with clnically significant arrhytmia) / total patients	1 month
Secondary	Arrhythmia detection rate	Compare the arrhythmia diagnosis rate between the two devices.	3 month
Secondary	Cost-effectiveness	Compare Total medical cost incurred for arrhythmia symptoms between the two devices	3 month
Secondary	Chagne of Quality of Life	Compare Quality Of Life using Euro QOL-5D-5L between the two devices	Baseline, 3 month
Secondary	User convenience	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	3 month