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| Name | Class |
|---|---|
| ICON plc | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrial fibrillation (AFib) | Active Comparator | Patient with known history of AFib who are in AFib at the time of study screening. |
|
| Non-Afib | Active Comparator | Patient with no known diagnosis of AFib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OMRON blood pressure monitor with AFib screening feature | Device | Blood pressure measurement by an oscillometric blood pressure monitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 1 day |
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Inclusion Criteria:
Subjects are eligible to participate in the study if they meet all of the following criteria. AFib participants must meet criteria 1-5. non-AFib participants must meet criteria 1-3 and 6-7.
Exclusion Criteria:
Participants will be excluded from the study if they meet any of the following criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Accelacare of DuPage Medical Group | Winfield | Illinois | 60190 | United States | ||
| Accelacare of MacFarland Clinic |
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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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Prospective, parallel-cohort, open label, non-randomized study
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| Microlife WatchBP Home A | Device | Blood pressure measurement by an oscillometric blood pressure monitor |
|
| Ames |
| Iowa |
| 50010 |
| United States |
| Accelacare of Charlotte | Charlotte | North Carolina | 28209 | United States |
| Accelacare of Wilmington | Wilmington | North Carolina | 28401 | United States |
| Accelacare of Charleston | Charleston | South Carolina | 29464 | United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |