Evaluation of Blood Pressure Monitor With AFib Screening Feature

NCT05599308 | Completed FDA Device

• 1 other identifier: HDV-CTD-210151
• Study Type: interventional
• Target: 574
• Locations: 1 country
• Sites: 5

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Atrial fibrillation (AFib)

ACTIVE COMPARATOR

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; Device: Microlife WatchBP Home A

Non-Afib

ACTIVE COMPARATOR

Patient with no known diagnosis of AFib

Device: OMRON blood pressure monitor with AFib screening feature; Device: Microlife WatchBP Home A

Interventions

OMRON blood pressure monitor with AFib screening feature DEVICE

Blood pressure measurement by an oscillometric blood pressure monitor

Atrial fibrillation (AFib); Non-Afib

Microlife WatchBP Home A DEVICE

Blood pressure measurement by an oscillometric blood pressure monitor

Atrial fibrillation (AFib); Non-Afib

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Omron Healthcare Co., Ltd.: lead
• ICON plc: collaborator

Study Sites (5)

Accelacare of DuPage Medical Group

Winfield, Illinois, 60190, United States

Location

Accelacare of MacFarland Clinic

Ames, Iowa, 50010, United States

Location

Accelacare of Charlotte

Charlotte, North Carolina, 28209, United States

Location

Accelacare of Wilmington

Wilmington, North Carolina, 28401, United States

Location

Accelacare of Charleston

Charleston, South Carolina, 29464, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, parallel-cohort, open label, non-randomized study

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 31, 2022
• Study Start: September 6, 2022
• Primary Completion: April 11, 2023
• Study Completion: April 11, 2023
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)