Evaluation of Blood Pressure Monitor With AFib Screening Feature

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: OMRON blood pressure monitor with AFib screening feature; Device: Microlife WatchBP Home A

• Registration Number: NCT05599308
• Lead Sponsor: Omron Healthcare Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-06
• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-31
• Status Verified: 2023-04
• Primary Completion: 2023-04-11
• Study Completion: 2023-04-11
• Last Update Submitted: 2023-04-27
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 574

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atrial fibrillation (AFib)	OMRON blood pressure monitor with AFib screening feature	Patient with known history of AFib who are in AFib at the time of study screening.
Non-Afib	OMRON blood pressure monitor with AFib screening feature	Patient with no known diagnosis of AFib
Non-Afib	Microlife WatchBP Home A	Patient with no known diagnosis of AFib
Atrial fibrillation (AFib)	Microlife WatchBP Home A	Patient with known history of AFib who are in AFib at the time of study screening.

Primary Outcome Measures

Name	Time	Method
Sensitivity	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.
Specificity	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.

Trial Locations

Locations (5)

Accelacare of MacFarland Clinic; 🇺🇸 Ames, Iowa, United States

Accelacare of Charlotte; 🇺🇸 Charlotte, North Carolina, United States

Accelacare of DuPage Medical Group; 🇺🇸 Winfield, Illinois, United States

Accelacare of Wilmington; 🇺🇸 Wilmington, North Carolina, United States

Accelacare of Charleston; 🇺🇸 Charleston, South Carolina, United States