Hativ® ELectrocardiogram Monitoring on Patients With Suspected Arrhythmia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arrhythmia
- Sponsor
- Wonju Severance Christian Hospital
- Enrollment
- 588
- Locations
- 3
- Primary Endpoint
- Diagnostic yield
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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.
Investigators
Young Jun Park
Assistant Professor
Wonju Severance Christian Hospital
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
Outcomes
Primary Outcomes
Diagnostic yield
Time Frame: 1 month
(Number of patient with triggered event without arrhythmia + Number of patients with clnically significant arrhytmia) / total patients
Secondary Outcomes
- Arrhythmia detection rate(3 month)
- Cost-effectiveness(3 month)
- Chagne of Quality of Life(Baseline, 3 month)
- User convenience(3 month)