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OpenTrials
Completed

NCT Number: NCT05599308

Evaluation of Blood Pressure Monitor With AFib Screening Feature

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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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Accelacare of DuPage Medical Group, Winfield, Illinois, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • 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

Exclusion criteria

  • 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.

Treatment and study plan

OMRON blood pressure monitor with AFib screening feature

Device

Blood pressure measurement by an oscillometric blood pressure monitor

Microlife WatchBP Home A

Device

Blood pressure measurement by an oscillometric blood pressure monitor

Primary outcomes

  1. Sensitivity

    Time frame: 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.

  2. Specificity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Omron Healthcare Co., Ltd.

Industry

Collaborators

  • ICON plc

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 31, 2022
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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