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 the clinical performance of the AFib-Chek device (a.k.a. Device) on human participants.
The primary purpose of this study is to demonstrate that the ECD signal acquired by the AFGen1 device is as of adequate quality and is suitable to support its intended use for the detection of AFib.
Study Type
OBSERVATIONAL
Enrollment
38
Participant wears the device for 7 days
Participant wears the device in conjunction with a standard ECG
Clayton Sleep Institute
St Louis, Missouri, United States
Quantitative Evaluation
For the quantitative evaluation of the mean and standard deviation of the QRS correlations for all study subjects and for the end of the wear period for those relevant subjects, the mean cor- relation coefficient must be greater than 0.95 and standard deviation must be less than 0.05 to validate a 95% confidence interval with significant factor of assurance.
Time frame: 7 days
Qualitative Equivalence Evaluation
For the qualitative equivalence evaluation according to the two cardiologists the confirmation of equivalence must be greater than 95%.
Time frame: 7 days
Adhesive performance
For the adhe sive performance element of the stud y; t he overall average wear time for the de- vice must be greater than 5 days
Time frame: 7 days
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