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Recruiting NCT06250712

Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia

No phase Interventional Arrhythmia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Continous ECG Patch, Intermittent handheld ECG.
Who it may be relevant to
Registry conditions: Arrhythmia. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The HELP-A study is a multicenter, randomized, controlled trial. A total of 588 patients were enrolled during the 4-year enrollment period and followed for 1 month. This study aims to compare the diagnostic yield of a continuous ECG patch versus an intermittent handheld ECG in patients with arrhythmia symptoms.

Detailed description

The HELP-A study is a multicenter, randomized, controlled trial designed to compare the diagnostic yield, arrhythmia detection rate, user convenience, and cost-effectiveness of a continuous ECG patch versus an intermittent handheld ECG in patients with arrhythmia symptoms. The study enrolls patients who have symptoms suggestive of arrhythmia but remain undiagnosed on a 12-lead ECG and require additional testing. A total of 588 patients will be enrolled during the 4-year enrollment period and followed for 3 months. Patients will be randomly assigned to either a continuous patch ECG or an intermittent handheld ECG and monitored for one month. If no diagnosis is made after one month, patients will cross over to the other device and be monitored for an additional month.

Interventions

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

Primary outcome measures

  • Diagnostic yield [Time frame: 1 month]
Secondary outcome measures (4)
  • Arrhythmia detection rate [Time frame: 3 month]
  • Cost-effectiveness [Time frame: 3 month]
  • Chagne of Quality of Life [Time frame: Baseline, 3 month]
  • User convenience [Time frame: 3 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
  • Patient who had syncope

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

South Korea · 4 centers
  • Chonnam National University Hospital — Gwangju
  • Wonju Severance Christian Hospital — Wŏnju
  • Hallym University Dongtan Sacred Heart Hospital — Gyeonggi-do
  • Korea anam hospital — Seoul

Publications

  • 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. PMID 21697315
  • 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
  • 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

Identifiers

NCT: NCT06250712 · CR223024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗