Health TrialsbyHealthPanel

Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia

ConditionArrhythmia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorWonju Severance Christian Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Patients who can use a smartphone

Disqualifiers

Patients who have cardiac implantable electronic devices(CIEDs)

Patients who can't use handheld ECG

Trial design

Design model

Parallel

Treatments tested in this trial

  • Continous ECG Patch

    Device

    Using a continuous patch ECG for 1 week during 1 month

  • Intermittent handheld ECG

    Device

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

Treatment groups

588 Participants
are divided into 2 treatment groups
Group A: Continous ECG PatchExperimental treatment 1 intervention
Group B: Intermittent handheld ECGActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic yield

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

Time frame
1 month

Secondary outcomes

1

Arrhythmia detection rate

Compare the arrhythmia diagnosis rate between the two devices.

Time frame
3 month
2

Cost-effectiveness

Compare Total medical cost incurred for arrhythmia symptoms between the two devices

Time frame
3 month
3

Chagne of Quality of Life

Compare Quality Of Life using Euro QOL-5D-5L between the two devices

Time frame
Baseline, 3 month
4

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

Time frame
3 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wonju Severance Christian Hospital

Lead sponsor

Source ClinicalTrials.gov
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