Atrial Fibrillation
Conditions
Brief summary
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.
Interventions
DEVICEOMRON blood pressure monitor with AFib screening feature
Blood pressure measurement by an oscillometric blood pressure monitor
DEVICEMicrolife WatchBP Home A
Blood pressure measurement by an oscillometric blood pressure monitor
Sponsors
ICON plc
Omron Healthcare Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Prospective, parallel-cohort, open label, non-randomized study
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
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. 1. Age ≥ 22 years old 2. Arm size within 22 cm to 42 cm in circumference 3. Participants who have an adequate understanding about the study and have given informed written consent before participation 4. Participants who were diagnosed with AFib and have regularly seen a cardiovascular specialist 5. Participants who have atrial fibrillation symptoms on ECG at the time of data collection 6. Participants who have never been diagnosed with atrial fibrillation 7. Participants who do not have AFib symptoms on ECG at data collection time
Exclusion criteria
* Participants will be excluded from the study if they meet any of the following criteria. 1. Subjects who have difficulty in ECG or blood pressure measurement due to skin rashes or wounds on the chest or arm 2. Women who are pregnant at the time of study participation. 3. Subjects who have had a mastectomy. 4. Subjects with pacemakers and/or defibrillators. 5. Subjects who have difficulty in measuring blood pressure or ECG measurements in the sitting position. 6. Subjects who are hospitalized (in-patients) 7. Subjects whose pulse rate is less than 40 beats/minute or more than 180 beats/minute. 8. Subjects who have had an arterio-venous shunt or an intravascular access on either arms. 9. Subjects who have heart failure class III or IV. 10. Subjects who at the beginning of the scheduled study time experience any of the following newly developed conditions within the past 3 hours: chest pain, paralysis or numbness (face, arm or leg), trouble speaking or understanding, visual field loss in one or both eyes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | 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. |
| Specificity | 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. |
Countries
United States
Outcome results
None listed