Evaluation of Blood Pressure Monitor With AFib Screening Feature
NCT ID: NCT05599308
Last Updated: 2023-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
574 participants
INTERVENTIONAL
2022-09-06
2023-04-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Atrial fibrillation (AFib)
Patient with known history of AFib who are in AFib at the time of study screening.
OMRON blood pressure monitor with AFib screening feature
Blood pressure measurement by an oscillometric blood pressure monitor
Microlife WatchBP Home A
Blood pressure measurement by an oscillometric blood pressure monitor
Non-Afib
Patient with no known diagnosis of AFib
OMRON blood pressure monitor with AFib screening feature
Blood pressure measurement by an oscillometric blood pressure monitor
Microlife WatchBP Home A
Blood pressure measurement by an oscillometric blood pressure monitor
Interventions
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OMRON blood pressure monitor with AFib screening feature
Blood pressure measurement by an oscillometric blood pressure monitor
Microlife WatchBP Home A
Blood pressure measurement by an oscillometric blood pressure monitor
Eligibility Criteria
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Inclusion Criteria
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
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.
22 Years
ALL
Yes
Sponsors
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ICON plc
INDUSTRY
Omron Healthcare Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Accelacare of Charleston
Charleston, South Carolina, United States
Countries
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Other Identifiers
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HDV-CTD-210151
Identifier Type: -
Identifier Source: org_study_id
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