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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
574
Blood pressure measurement by an oscillometric blood pressure monitor
Blood pressure measurement by an oscillometric blood pressure monitor
Accelacare of DuPage Medical Group
Winfield, Illinois, United States
Accelacare of MacFarland Clinic
Ames, Iowa, United States
Accelacare of Charlotte
Charlotte, North Carolina, United States
Accelacare of Wilmington
Wilmington, North Carolina, United States
Sensitivity
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
Specificity
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.
Time frame: 1 day
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Accelacare of Charleston
Charleston, South Carolina, United States