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Evaluation of Blood Pressure Monitor With AFib Screening Feature

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OMRON blood pressure monitor with AFib screening feature
Microlife WatchBP Home A
Sponsored by
Omron Healthcare Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Atrial Fibrillation

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Accelacare of DuPage Medical Group
  • Accelacare of MacFarland Clinic
  • Accelacare of Charlotte
  • Accelacare of Wilmington
  • Accelacare of Charleston

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Atrial fibrillation (AFib)

Non-Afib

Arm Description

Patient with known history of AFib who are in AFib at the time of study screening.

Patient with no known diagnosis of AFib

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 12, 2022
Last Updated
April 27, 2023
Sponsor
Omron Healthcare Co., Ltd.
Collaborators
ICON plc
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1. Study Identification

Unique Protocol Identification Number
NCT05599308
Brief Title
Evaluation of Blood Pressure Monitor With AFib Screening Feature
Official Title
Evaluation of Blood Pressure Monitor With AFib Screening Feature
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
April 11, 2023 (Actual)
Study Completion Date
April 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Omron Healthcare Co., Ltd.
Collaborators
ICON plc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, parallel-cohort, open label, non-randomized study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
574 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atrial fibrillation (AFib)
Arm Type
Active Comparator
Arm Description
Patient with known history of AFib who are in AFib at the time of study screening.
Arm Title
Non-Afib
Arm Type
Active Comparator
Arm Description
Patient with no known diagnosis of AFib
Intervention Type
Device
Intervention Name(s)
OMRON blood pressure monitor with AFib screening feature
Intervention Description
Blood pressure measurement by an oscillometric blood pressure monitor
Intervention Type
Device
Intervention Name(s)
Microlife WatchBP Home A
Intervention Description
Blood pressure measurement by an oscillometric blood pressure monitor
Primary Outcome Measure Information:
Title
Sensitivity
Description
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.
Time Frame
1 day
Title
Specificity
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Accelacare of DuPage Medical Group
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
Accelacare of MacFarland Clinic
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Accelacare of Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Accelacare of Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Accelacare of Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Blood Pressure Monitor With AFib Screening Feature

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