OMRON blood pressure monitor with AFib screening feature
DeviceBlood pressure measurement by an oscillometric blood pressure monitor
NCT Number: NCT05599308
This study aims to evaluate the safety and effectiveness of the Omron blood pressure (BP) monitor with AFib screening feature. The primary outcome is to validate if the Omron BP-monitor with AFib screening feature meets acceptance criteria in sensitivity and specificity. The acceptance criteria of the sensitivity and specificity should be statistically non-inferior to those of primary predicate device.
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Notify Me22 year and older
All sexes
Interventional
Not applicable
Accelacare of DuPage Medical Group, Winfield, Illinois, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Blood pressure measurement by an oscillometric blood pressure monitor
Blood pressure measurement by an oscillometric blood pressure monitor
Time frame: 1 day
To validate if the BP-monitor with AFib screening feature meets the acceptance criteria in sensitivity. Acceptance criteria is that sensitivity of the Omron BP-monitor with AFib screening feature should be statistically non-inferior to that of the primary predicate device.
Time frame: 1 day
To validate if the BP-monitor with AFib screening feature meets the acceptance criteria in specificity. Acceptance criteria is that specificity of the Omron BP-monitor with AFib screening feature should be statistically non-inferior to that of the primary predicate device.
Omron Healthcare Co., Ltd.
Industry
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