Evaluation of Blood Pressure Monitor With AFib Screening Feature

Completed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT05599308

Run by

Omron Healthcare Co., Ltd.

People needed

574

Starts

2022-09-06

Expected to finish

2023-04-11

Last updated by the study team

2023-04-28

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• Age ≥ 22 years old
• Arm size within 22 cm to 42 cm in circumference
• Participants who have an adequate understanding about the study and have given informed written consent before participation
• Participants who were diagnosed with AFib and have regularly seen a cardiovascular specialist
• Participants who have atrial fibrillation symptoms on ECG at the time of data collection
• Participants who have never been diagnosed with atrial fibrillation
• Participants who do not have AFib symptoms on ECG at data collection time

You may not qualify if…

• Participants will be excluded from the study if they meet any of the following criteria.
• Subjects who have difficulty in ECG or blood pressure measurement due to skin rashes or wounds on the chest or arm
• Women who are pregnant at the time of study participation.
• Subjects who have had a mastectomy.
• Subjects with pacemakers and/or defibrillators.
• Subjects who have difficulty in measuring blood pressure or ECG measurements in the sitting position.
• Subjects who are hospitalized (in-patients)
• Subjects whose pulse rate is less than 40 beats/minute or more than 180 beats/minute.
• Subjects who have had an arterio-venous shunt or an intravascular access on either arms.
• Subjects who have heart failure class III or IV.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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