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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: OMRON blood pressure monitor with AFib screening feature; Device: Microlife WatchBP Home A

• Study Type: Interventional
• Enrollment (Actual): 574
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Winfield, Illinois, United States, 60190
      • Accelacare of DuPage Medical Group
  • Iowa
    • Ames, Iowa, United States, 50010
      • Accelacare of MacFarland Clinic
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
      • Accelacare of Charlotte
    • Wilmington, North Carolina, United States, 28401
      • Accelacare of Wilmington
  • South Carolina
    • Charleston, South Carolina, United States, 29464
      • Accelacare of Charleston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Atrial fibrillation (AFib); Patient with known history of AFib who are in AFib at the time of study screening.	Device: OMRON blood pressure monitor with AFib screening feature; Blood pressure measurement by an oscillometric blood pressure monitor; Device: Microlife WatchBP Home A; Blood pressure measurement by an oscillometric blood pressure monitor
Active Comparator: Non-Afib; Patient with no known diagnosis of AFib	Device: OMRON blood pressure monitor with AFib screening feature; Blood pressure measurement by an oscillometric blood pressure monitor; Device: Microlife WatchBP Home A; Blood pressure measurement by an oscillometric blood pressure monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	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.	1 day
Specificity	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.	1 day

Collaborators and Investigators

• Sponsor: Omron Healthcare Co., Ltd.
• Collaborators: ICON plc

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2022
• Primary Completion (Actual): April 11, 2023
• Study Completion (Actual): April 11, 2023

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: HDV-CTD-210151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No