Evaluation of Blood Pressure Monitor With AFib Screening Feature

Atrial Fibrillation Clinical Trial

Official title:

Evaluation of Blood Pressure Monitor With AFib Screening Feature

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05599308
• Other study ID #: HDV-CTD-210151
• Status: Completed
• Phase: N/A
• Start date: September 6, 2022
• Est. completion date: April 11, 2023

Study information

• Verified date: April 2023
• Source: Omron Healthcare Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 574
• Est. completion date: April 11, 2023
• Est. primary completion date: April 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• OMRON blood pressure monitor with AFib screening feature
Blood pressure measurement by an oscillometric blood pressure monitor
• Microlife WatchBP Home A
Blood pressure measurement by an oscillometric blood pressure monitor

Locations

Country	Name	City	State
United States	Accelacare of MacFarland Clinic	Ames	Iowa
United States	Accelacare of Charleston	Charleston	South Carolina
United States	Accelacare of Charlotte	Charlotte	North Carolina
United States	Accelacare of Wilmington	Wilmington	North Carolina
United States	Accelacare of DuPage Medical Group	Winfield	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Omron Healthcare Co., Ltd.	ICON plc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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