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The purpose of this study is to demonstrate that the ZywieAI analysis algorithm can be used to analyze ECG data collected from ZywieZ3 devices with non-traditional lead placement over a 24-hour simulated use period by human subjects.
At least 150 subjects will participate in this study over a 24-hour test period. The subjects must have been diagnosed with a known condition such as Atrial Fibrillation (AF), Tachycardia, Bradycardia, Premature Ventricular Contractions (PVC/VEB), and/or Premature Atrial Contractions (PAC), etc.
A Testing Facility analyst will conduct an initial visual evaluation of the level of skin adhesion for the Test Device. The Testing Facility analyst will apply the Test device adhesive on the subject and initiate ECG data collection. Subjects will observe a 5-minute stabilization period to ensure the device is connected appropriately and has a stable input signal. Subjects will be allowed to leave the Testing Facility for the next 24 hours. During this period, subjects will follow the instructions for use provided by the Sponsor and engage in normal routine activities. After the 24-hour recording, subjects will return to the Testing Facility, and an analyst will then remove the Test Device.
Two cardiologists will review the collected ECG data from the 24-hour wear time to identify episodes of arrhythmia. A third cardiologist will be used to review the ECG data collected if the first two do not agree with their assessment. The Sponsor will download the ECG data for the Test Device from a cloud-based data repository to complete the data analysis according to the Sponsor's statistical analysis plan. The cardiologist's assessment will be compared with the analysis by the ZywieAI algorithm. A summary of the ECG statistical analysis comparing the agreement of the cardiologists will be included as an appendix to the final report for the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evaluation of 24-hour ECG Data from Test Device by a Test Analysis Algorithm | Other | ECG data will be collected from subjects with previously diagnosed heart arrhythmias by a test algorithm. ECG data collected using a Test Device with non-traditional lead placement worn for a 24-hour period. The Test Algorithm analysis will be compared to assessments of the ECG data by 2 cardiologists with a 3rd cardiologist employed when there is no agreement by the 2 cardiologists. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Algorithm and Test Device | Device | Test Algorithm analysis of 24-hour ECG Data collected with a Test Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demonstration that the ZywieAI analysis algorithm can be used to analyze ECG data collected from ZywieZ3 devices with non-traditional lead placement over a 24-hour simulated use period by human subjects | Two cardiologists will review the collected ECG data from the 24-hour wear time to identify episodes of arrhythmia. A third cardiologist will be used to review the ECG data collected if the first two do not agree with their assessment. The Sponsor will download the ECG data for the Test Device from a cloud-based data repository to complete the data analysis by ZywieAI algorithm identifying cardiac anomalies. The cardiologist's assessment will be compared with the analysis by the ZywieAI. | 24 Hours after Application of Test Device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher M Beausoleil, B.S. | Bioscience of Bozeman LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bioscience of Bozeman, LLC | Bozeman | Montana | 59715 | United States |
There are no plans for publishing the data from this trial.
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D013610 | Tachycardia |
| D001919 | Bradycardia |
| D018879 | Ventricular Premature Complexes |
| D018880 | Atrial Premature Complexes |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000075224 | Cardiac Conduction System Disease |
| D005117 | Cardiac Complexes, Premature |
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