Evaluation of Blood Pressure Monitor With AFib Screening Feature

• Sponsor: Omron Healthcare Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05599308
• Collaborator: ICON plc (Industry)
• Enrollment: 600
• Locations: 5
• Arms: 2
• Anticipated Duration (Months): 5.7
• Patients Per Site: 120
• Patients Per Site Per Month: 20.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: OMRON blood pressure monitor with AFib screening feature; Device: Microlife WatchBP Home A	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 600 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective, parallel-cohort, open label, non-randomized studyProspective, parallel-cohort, open label, non-randomized study
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Evaluation of Blood Pressure Monitor With AFib Screening Feature
• Actual Study Start Date: Sep 6, 2022
• Anticipated Primary Completion Date: Feb 28, 2023
• Anticipated Study Completion Date: Feb 28, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Accelacare of DuPage Medical Group	Winfield	Illinois	United States	60190
2	Accelacare of MacFarland Clinic	Ames	Iowa	United States	50010
3	Accelacare of Charlotte	Charlotte	North Carolina	United States	28209
4	Accelacare of Wilmington	Wilmington	North Carolina	United States	28401
5	Accelacare of Charleston	Charleston	South Carolina	United States	29464

Sponsors and Collaborators

• Omron Healthcare Co., Ltd.
• ICON plc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Omron Healthcare Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05599308
• Other Study ID Numbers: HDV-CTD-210151
• First Posted: Oct 31, 2022
• Last Update Posted: Jan 18, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Jan 18, 2023