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

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.

Study Overview

• Status: Recruiting
• Conditions: Arrhythmia
• Intervention / Treatment: Device: Continous ECG Patch; Device: Intermittent handheld ECG

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 588
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Young Jun Park, MD; Phone Number: 82-33-741-0917; Email: pyj@yonsei.ac.kr

Study Locations

• Korea, Republic of
  • Gangwon-do
    • Wonju, Gangwon-do, Korea, Republic of, 26426
      • Recruiting
      • Wonju Severance Christian Hospital
      • Contact: Young Jun Park; Email: pyj@yonsei.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continous ECG Patch; In this arm, continuous patch ECG was used.	Device: Continous ECG Patch; Using a continuous patch ECG for 1 week during 1 month
Active Comparator: Intermittent handheld ECG; In this arm, intermittent handheld ECG was used.	Device: Intermittent handheld ECG; Using a handheld ECG twice daily and when symptoms are present during 1 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic yield	(Number of patient with triggered event without arrhythmia + Number of patients with clnically significant arrhytmia) / total patients	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arrhythmia detection rate	Compare the arrhythmia diagnosis rate between the two devices.	3 month
Cost-effectiveness	Compare Total medical cost incurred for arrhythmia symptoms between the two devices	3 month
Chagne of Quality of Life	Compare Quality Of Life using Euro QOL-5D-5L between the two devices	Baseline, 3 month
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

Collaborators and Investigators

• Sponsor: Wonju Severance Christian Hospital
• Investigators: Principal Investigator: Young Jun Park, MD, Wonju Severance Christian Hopsital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Arrhythmia; Dizziness; Palpitation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: CR223024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No