Atrial Fibrillation (AF)NCT06931288
Electronic Blood Pressure Monitor for Atrial Fibrillation Detection
A study testing Blood pressure monitor and Single-lead ECG in people with Atrial Fibrillation (AF), run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Study name: Study on the Effectiveness of Atrial Fibrillation Screening Using Electronic Blood Pressure Monitor with Atrial Fibrillation Detection Function Objective: This study compares an electronic blood pressure monitor (BP77A1T, Omron Healthcare, Kyoto, Japan) with single-lead electrocardiography for atrial… Read more about this study
- Who is it for?
- Ages 60 to 125 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Blood pressure monitor and Single-lead ECG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 125 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent form.
- Age ≥ 60 years.
- Able to cooperate with atrial fibrillation screening, complete questionnaires, and communicate normally.
Who cannot join
- 1. Participants with severe communication problems.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai 200025
Shanghai, Shanghai Municipality, 200025
Jiguang Wang, PhD, +86-21-64370045 ext. 610911, jiguangw@163.com
About this study
Official title: Study on the Effectiveness of Atrial Fibrillation Screening Using Electronic Blood Pressure Monitor With Atrial Fibrillation Detection Function
Study name: Study on the Effectiveness of Atrial Fibrillation Screening Using Electronic Blood Pressure Monitor with Atrial Fibrillation Detection Function
Objective: This study compares an electronic blood pressure monitor (BP77A1T, Omron Healthcare, Kyoto, Japan) with single-lead electrocardiography for atrial fibrillation detection in an elderly Chinese population.
Read more
Study design: This study is a cluster-randomized and controlled trial.
Study population: Men and women aged over 60 years meeting the inclusion/exclusion criteria.
Randomization and treatment: Eligible centers as clusters will be randomly assigned to either the single-lead electrocardiography group or the electronic blood pressure monitor group for atrial fibrillation detection.
Sample size: About 50 centers, at least 20,000 participants.
Timeline: Participants enrollment are expected to be performed from May 2025 to July 2026.
Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
Read the detailed description
Study name: Study on the Effectiveness of Atrial Fibrillation Screening Using Electronic Blood Pressure Monitor with Atrial Fibrillation Detection Function
Rationale: With the advancement of technology and the development of artificial intelligence, it has become possible to detect atrial fibrillation during routine blood pressure measurements. Previous studies have explored the accuracy of the blood pressure monitor for atrial fibrillation detection. However, the efficiency and adherence of using this device for large-scale population screening remain unknown.
Objective: This study compares an electronic blood pressure monitor (BP77A1T, Omron Healthcare, Kyoto, Japan) with single-lead electrocardiography for atrial fibrillation detection in an elderly Chinese population.
Study design: This study is a cluster-randomized and controlled trial. The eligible center as a cluster will be randomly assigned to either the single-lead electrocardiography group or the electronic blood pressure monitor group for atrial fibrillation detection.
Study population: Men and women aged over 60 years meeting the inclusion/exclusion criteria. Inclusion criteria included: 1) Signed and dated informed consent form. 2) Age ≥ 60 years. 3) Able to cooperate with atrial fibrillation screening, complete questionnaires, and communicate normally. The only exclusion criteria is severe communication problem.
Randomization and treatment: Eligible centers as clusters will be randomly assigned to either the single-lead electrocardiography group or the electronic blood pressure monitor group for atrial fibrillation detection. In the control group, a single-lead electrocardiography will be recorded for 30s with a handheld electrocardiography for atrial fibrillation detection. Each ECG rhythm strip will be reviewed and analyzed by a cardiologist from the research team. In the trial group, atrial fibrillation screening will be integrated into blood pressure measurements using the BP77A1T electronic blood pressure monitor (Omron Healthcare, Kyoto, Japan).
Sample size: About 50 centers, at least 20,000 participants.
Timeline: Participants enrollment are expected to be performed from May 2025 to July 2026.
Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Blood pressure monitor, Single-lead ECG
- Keywords
- Atrial Fibrillation, Detection, Electronic blood pressure monitor
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure monitorDevice
In the trial group, atrial fibrillation screening will be integrated into blood pressure measurements using the BP77A1T electronic blood pressure monitor (Omron Healthcare, Kyoto, Japan).
Single-lead ECGDevice
In the control group, a single-lead ECG will be recorded for 30s with a handheld ECG for atrial fibrillation detection. Each ECG rhythm strip will be reviewed and analyzed by a cardiologist from the research team.
| Study group | Role | What they receive |
|---|---|---|
| Single-lead ECG | Active comparator | Not described Receives: Device: Single-lead ECG |
| Blood pressure monitor | Experimental | Not described Receives: Device: Blood pressure monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in detection rates of atrial fibrillation between the blood pressure monitor and the single-lead ECG group.
Measured: Baseline
Secondary outcomes (1)
The difference in detection rates atrial fibrillation of between the blood pressure monitor and the single-lead ECG group among screening-positive participants.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start6 May 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The eligible center as a cluster will be randomly assigned to either the single-lead ECG group or the electronic blood pressure monitor group for atrial fibrillation detection.
- Masking
- None (open label)
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Guang Wang, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931288
- Sponsor's protocol ID
- AFSE
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effectiveness of Atrial Fibrillation Screening Using Electronic Blood Pressure Monitor With Atrial Fibrillation Detection Function
- ClinicalTrials.gov ID
- NCT06931288
- Acronym / sponsor ID
- AFSE
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Atrial Fibrillation, Detection, Electronic blood pressure monitor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 6 May 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 17 Apr 2025 (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.
Study name: Study on the Effectiveness of Atrial Fibrillation Screening Using Electronic Blood Pressure Monitor with Atrial Fibrillation Detection Function
Objective: This study compares an electronic blood pressure monitor (BP77A1T, Omron Healthcare, Kyoto, Japan) with single-lead electrocardiography for atrial fibrillation detection in an elderly Chinese population.
Study design: This study is a cluster-randomized and controlled trial.
Study population: Men and women aged over 60 years meeting the inclusion/exclusion criteria.
Randomization and treatment: Eligible centers as clusters will be randomly assigned to either the single-lead electrocardiography group or the electronic blood pressure monitor group for atrial fibrillation detection.
Sample size: About 50 centers, at least 20,000 participants.
Timeline: Participants enrollment are expected to be performed from May 2025 to July 2026.
Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
Detailed description
Study name: Study on the Effectiveness of Atrial Fibrillation Screening Using Electronic Blood Pressure Monitor with Atrial Fibrillation Detection Function
Rationale: With the advancement of technology and the development of artificial intelligence, it has become possible to detect atrial fibrillation during routine blood pressure measurements. Previous studies have explored the accuracy of the blood pressure monitor for atrial fibrillation detection. However, the efficiency and adherence of using this device for large-scale population screening remain unknown.
Objective: This study compares an electronic blood pressure monitor (BP77A1T, Omron Healthcare, Kyoto, Japan) with single-lead electrocardiography for atrial fibrillation detection in an elderly Chinese population.
Study design: This study is a cluster-randomized and controlled trial. The eligible center as a cluster will be randomly assigned to either the single-lead electrocardiography group or the electronic blood pressure monitor group for atrial fibrillation detection.
Study population: Men and women aged over 60 years meeting the inclusion/exclusion criteria. Inclusion criteria included: 1) Signed and dated informed consent form. 2) Age ≥ 60 years. 3) Able to cooperate with atrial fibrillation screening, complete questionnaires, and communicate normally. The only exclusion criteria is severe communication problem.
Randomization and treatment: Eligible centers as clusters will be randomly assigned to either the single-lead electrocardiography group or the electronic blood pressure monitor group for atrial fibrillation detection. In the control group, a single-lead electrocardiography will be recorded for 30s with a handheld electrocardiography for atrial fibrillation detection. Each ECG rhythm strip will be reviewed and analyzed by a cardiologist from the research team. In the trial group, atrial fibrillation screening will be integrated into blood pressure measurements using the BP77A1T electronic blood pressure monitor (Omron Healthcare, Kyoto, Japan).
Sample size: About 50 centers, at least 20,000 participants.
Timeline: Participants enrollment are expected to be performed from May 2025 to July 2026.
Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The eligible center as a cluster will be randomly assigned to either the single-lead ECG group or the electronic blood pressure monitor group for atrial fibrillation detection.
| Arm | Type | Receives |
|---|---|---|
| Single-lead ECG | Active comparator | Device: Single-lead ECG |
| Blood pressure monitor | Experimental | Device: Blood pressure monitor |
Who may qualify
- Ages
- 60 to 125 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed and dated informed consent form.
- Age ≥ 60 years.
- Able to cooperate with atrial fibrillation screening, complete questionnaires, and communicate normally.
Key exclusion criteria (1 listed)
- 1. Participants with severe communication problems.
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 |
|---|---|---|
| Blood pressure monitorIn the trial group, atrial fibrillation screening will be integrated into blood pressure measurements using the BP77A1T electronic blood pressure monitor (Omron Healthcare, Kyoto, Japan). | Device | Blood pressure monitor |
| Single-lead ECGIn the control group, a single-lead ECG will be recorded for 30s with a handheld ECG for atrial fibrillation detection. Each ECG rhythm strip will be reviewed and analyzed by a cardiologist from the research team. | Device | Single-lead ECG |
Primary outcome
The difference in detection rates of atrial fibrillation between the blood pressure monitor and the single-lead ECG group.
Time frame: Baseline
1 secondary outcome
The difference in detection rates atrial fibrillation of between the blood pressure monitor and the single-lead ECG group among screening-positive participants.
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
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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.
Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai 200025
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood pressure monitor and Single-lead ECG in people with Atrial Fibrillation (AF), run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in detection rates of atrial fibrillation between the blood pressure monitor and the single-lead ECG group. (time frame: Baseline). 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 17 Apr 2025.