Atrial FibrillationNCT05599308
Evaluation of Blood Pressure Monitor With AFib Screening Feature
A study testing OMRON blood pressure monitor with AFib screening feature and Microlife WatchBP Home A in people with Atrial Fibrillation, run by Omron Healthcare Co., Ltd. at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- OMRON blood pressure monitor with AFib screening feature and Microlife WatchBP Home A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 574 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Sep 2022to 11 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Accelacare of MacFarland Clinic
Ames, Iowa, 50010
Accelacare of Charleston
Charleston, South Carolina, 29464
Accelacare of Charlotte
Charlotte, North Carolina, 28209
Accelacare of Wilmington
Wilmington, North Carolina, 28401
Accelacare of DuPage Medical Group
Winfield, Illinois, 60190
About this study
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
- Being tested
- OMRON blood pressure monitor with AFib screening feature, Microlife WatchBP Home A
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMRON blood pressure monitor with AFib screening featureDevice
Blood pressure measurement by an oscillometric blood pressure monitor
Microlife WatchBP Home ADevice
Blood pressure measurement by an oscillometric blood pressure monitor
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation (AFib) | Active comparator | Patient with known history of AFib who are in AFib at the time of study screening. Receives: 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 Receives: Device: OMRON blood pressure monitor with AFib screening feature; Device: Microlife WatchBP Home A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start6 Sep 2022
- Primary completion11 Apr 2023
- Study completion11 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, parallel-cohort, open label, non-randomized study
- Masking
- None (open label)
- Enrolment
- 574 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omron Healthcare Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599308
- Sponsor's protocol ID
- HDV-CTD-210151
- Status last verified
- Apr 2023
- First submitted
- 12 Oct 2022
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Blood Pressure Monitor With AFib Screening Feature
- ClinicalTrials.gov ID
- NCT05599308
- Acronym / sponsor ID
- HDV-CTD-210151
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 574 participants (actual)
- Lead sponsor
- Omron Healthcare Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 11 Apr 2023 (actual)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, parallel-cohort, open label, non-randomized study
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation (AFib) | Active comparator | Device: OMRON blood pressure monitor with AFib screening feature, Device: Microlife WatchBP Home APatient with known history of AFib who are in AFib at the time of study screening. |
| Non-Afib | Active comparator | Device: OMRON blood pressure monitor with AFib screening feature, Device: Microlife WatchBP Home APatient with no known diagnosis of AFib |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- Participants will be excluded from the study if they meet any of the following criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMRON blood pressure monitor with AFib screening featureBlood pressure measurement by an oscillometric blood pressure monitor | Device | Atrial fibrillation (AFib), Non-Afib |
| Microlife WatchBP Home ABlood pressure measurement by an oscillometric blood pressure monitor | Device | Atrial fibrillation (AFib), Non-Afib |
Primary outcome
Sensitivity
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMRON blood pressure monitor with AFib screening feature and Microlife WatchBP Home A in people with Atrial Fibrillation, run by Omron Healthcare Co., Ltd. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.