Clinical trial NCT06250712: Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia
Official title: Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arrhythmia
Keywords: Palpitation
Dizziness
Arrhythmia
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 588
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic yield
timeFrame: 1 month
Secondary outcomes:
measure: Arrhythmia detection rate
timeFrame: 3 month
measure: Cost-effectiveness
timeFrame: 3 month
measure: Chagne of Quality of Life
timeFrame: Baseline, 3 month
measure: User convenience
timeFrame: 3 month
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gangwon-do
Study officials:
affiliation: Wonju Severance Christian Hopsital
name: Young Jun Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.