Atrial Fibrillation
Conditions
Brief summary
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: 1. Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation compared with physician-adjudicated Gold Standard ECG recorder. 2. Waveform qualitative assessment 3. 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.
Interventions
DEVICEWearable Dynamic ECG Recorder
use a Wearable Dynamic ECG Recorder to record heart rate and atrial fibrillation
DEVICE12-lead ECG recordings
use a 12-lead ECG recordings to record heart rate and atrial fibrillation
Sponsors
Huami Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Consistent rate of atrial fibrillation diagnosis | second 60 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation | second 60 | 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. |
| waveform qualitative assessment 1 | second 60 | 1)The proportion of paired ECG strips appear to overlay to the unaided eye \> 0.80. |
| waveform qualitative assessment 2 | second 60 | 2)The proportion of paired R-wave amplitude measurements within 2 mm of each other \> 0.80 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety measures 2 | second 60 | 2\. Adverse event (AE) |
| Safety measures 3 | second 60 | 3\. Equipment defector failure for example: unable to wear, no results output, signal interruption. |
| Safety measures 1 | second 60 | 1.Scoring system for skin reaction:No erythema, score 0; Very slight erythema (barely perceptible), score 1; Well-defined erythema, score2;Moderate erythema, score 3;Severe erythema (beet-redness) to eschar formation preventing grading of erythema, score 4. |
Countries
China
Contacts
Primary ContactRuogu li, MD
Outcome results
None listed