Evaluation of Blood Pressure Monitor With AFib Screening Feature

Last updated: April 27, 2023
Sponsor: Omron Healthcare Co., Ltd.
Overall Status: Completed

Phase

N/A

Condition

Chest Pain

Arrhythmia

Atrial Fibrillation

Treatment

N/A

Clinical Study ID

NCT05599308
HDV-CTD-210151
  • Ages > 22
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects are eligible to participate in the study if they meet all of the followingcriteria. AFib participants must meet criteria 1-5. non-AFib participants must meetcriteria 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 giveninformed written consent before participation
  4. Participants who were diagnosed with AFib and have regularly seen acardiovascular specialist
  5. Participants who have atrial fibrillation symptoms on ECG at the time of datacollection
  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

Exclusion Criteria:

  • Participants will be excluded from the study if they meet any of the followingcriteria.
  1. Subjects who have difficulty in ECG or blood pressure measurement due to skinrashes 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 inthe sitting position.
  6. Subjects who are hospitalized (in-patients)
  7. Subjects whose pulse rate is less than 40 beats/minute or more than 180beats/minute.
  8. Subjects who have had an arterio-venous shunt or an intravascular access oneither 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 thefollowing 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.

Study Design

Total Participants: 574
Study Start date:
September 06, 2022
Estimated Completion Date:
April 11, 2023

Connect with a study center

  • Accelacare of DuPage Medical Group

    Winfield, Illinois 60190
    United States

    Site Not Available

  • Accelacare of MacFarland Clinic

    Ames, Iowa 50010
    United States

    Site Not Available

  • Accelacare of Charlotte

    Charlotte, North Carolina 28209
    United States

    Site Not Available

  • Accelacare of Wilmington

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Accelacare of Charleston

    Charleston, South Carolina 29464
    United States

    Site Not Available

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