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AFGen1 is indicated for use on symptomatic or asymptomatic adults who are at risk of developing or who have atrial fibrillation, where a software assisted analysis of ambulatory ECG is needed to identify episodes of Afib. The purpose of this study is to establish further evidence for the clinical performance of AFGen1 on human participants.
The primary purpose of this study is to demonstrate the ECG signal acquired by the AFGen1 device is of adequate quality and is suitable to support its intended use for the detection of Afib. This will be evaluated by comparing the ECG data acquired by AFGen1 to that acquired by an FDA cleared 12-lead ECG device using a Bland-Altman analysis of the R-R intervals and R amplitude measurements and Eigenvector magnitudes derived from principal component analyses of simultaneously captured waveforms measured by both devices by both devices. The ECG waveforms from both devices will also be adjudicated by 2 independent cardiologists. The study will also seek to demonstrate that there is no degradation in the quality of the ECG signal it acquires when the device is placed in an anticipated misplacement position to that directed by the instructions for use of the device. Finally the study will seek to confirm the adhesive performance of the device is appropriate to support its intended use per the requirements of sections 4.4 and 5.4 of ANSI AAMI EC12-1 . Another purpose of the study is to collect extended 5 minute ECG recordings by the subject periodically triggering the device while wearing the device for 7 (+3) days. This data will be used for product development purposes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wear AFGen1 for at least 7 days | Wear AFGen1 for 7 to 10 days. ECG co-measurement with 12 lead device at start and periodic measurements of ECG with AFGen1 during wear period |
| |
| Misplacement Study Group | Wear AFGen1 device in misplaced position compared to wearing device in standard position as directed by instructions for use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECG co-measurement | Device | Measure ECG with 12 lead device at same time that AFGen1 is monitoring ECG |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bland-Altman Comparison | The waveform characteristics for both the 7- day wear and misplacement elements of this study, the limits of agreement (LoA) from the Bland-Altman analyses shall not exceed the the maximum allowed clinically significant difference between methods i.e. 80ms for R-R. 0.2 mV for R-peak amplitude) for 95% of the subjects on a per-subject basis. | 1 day |
| Qualitative Evaluation | For the qualitative equivalence evaluation according to the two cardiologists confirmation of equivalence must be greater than 95%. | 1 day |
| Adhesive performance | The overall average wear time for the device must be greater than 7-days. | 7 to 10 days |
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Inclusion Criteria:
1. 18+ willing to sign the consent form
Exclusion Criteria:
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The study shall involve up to twenty (20) participants divided into 2 cohorts. The first study cohort will comprise up to fifteen (15) participants (at least 5 male and 5 female) who will wear the device for 7 days. The second cohort of five (5) participants will participate in the misplacement part of the study
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| Name | Affiliation | Role |
|---|---|---|
| Allison Willis, BSN RN | Unafilliated | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1808 49Th St Ct NW | Gig Harbor | Washington | 98335 | United States |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Periodic ECG triggered measurement | Device | Subject triggers AFGen1 to perform an extended measurement during wear period |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |