Evaluation of the Detection of Atrial Fibrillation by a Wearable Dynamic ECG Recorder

Study Overview
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Brief Summary
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A Randomized, Crossover Trial is conducted to Evaluate Consistency Atrial fibrillation diagnosis between the Wearable Dynamic ECG Recorder and the Control device. In this investigation, the following indicators is also evaluated: Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation compared with physician-adjudicated Gold Standard ECG recorder. Waveform qualitative assessment Safety incident assessments. 114 subjects (60 healthy subjects in phase I and 54 subjects with atrial fibrillation diagnosis in phase II) are enrolled in the investigation according to the criteria.

Official Title
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Evaluation of the Consistency Between the Detection of Atrial Fibrillation by a Wearable Dynamic ECG Recorder and a Control Instrument

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Wearable Dynamic ECG Recorder
* Device: 12-lead ECG recordings


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - All study participants must be able to provide written informed consent prior to study procedure. This study has 2 Phases. Phase 1: Health conscious individuals > 18 years of age Phase 2: > 18 years of age non critical patients ever diagnosed with atrial fibrillation Exclusion Criteria: • < 18 years old Unable to consent Phase 1: > 80 years of age Previous history of cardiac disease (e.g., atrial fibrillation, myocardial infarction, congestive heart failure) current status of non-sinus heart rhythm Phase 2: - Critical patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: use two kinds of device successively<br>the same participant use a Wearable Dynamic ECG Recorder and 12-lead ECG to record heart rate and atrial fibrillation | Device: Wearable Dynamic ECG Recorder<br>* use a Wearable Dynamic ECG Recorder to record heart rate and atrial fibrillation<br>Device: 12-lead ECG recordings<br>* use a 12-lead ECG recordings to record heart rate and atrial fibrillation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consistent rate of atrial fibrillation diagnosis | Electrical signals from ECG electrodes are collected with tested device and gold standard device. An automatic diagnosis of atrial fibrillation made with the tested device, and diagnosis of atrial fibrillation is made by the investigators with gold standard device. Diagnosis results include: with atrial fibrillation (AF), without atrial fibrillation (No AF), or indecipherable. After the diagnosis, the number of with atrial fibrillation (AF), without atrial fibrillation (No AF), or indecipherable cases measured by the two devices are calculated according to table 1, and then the results are evaluated for 3×3 matching consistency. | second 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation | Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation compared with physician-adjudicated Gold Standard ECG recorder. Per the protocol, only readable and classifiable (classifiable analysis set) paired recordings are included in the diagnostic performance assessment. | second 60 | 
| waveform qualitative assessment 1 | 1)The proportion of paired ECG strips appear to overlay to the unaided eye > 0.80. | second 60 | 
| waveform qualitative assessment 2 | 2)The proportion of paired R-wave amplitude measurements within 2 mm of each other > 0.80 | second 60 |