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Clinical Trial on the Efficacy and Safety of the Arm-Cuff Electronic Blood Pressure Monitor YE680B for Screening Patients with Atrial Fibrillation

Clinical Trial on the Efficacy and Safety of the Arm-Cuff Electronic Blood Pressure Monitor YE680B for Screening Patients with Atrial Fibrillation

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600120494
Enrollment
Unknown
Registered
2026-03-16
Start date
2026-03-16
Completion date
Unknown
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrial fibrillation

Interventions

Gold Standard:Single lead dynamic electrocardiograph
Index test:Arm-type electronic blood pressure monitor YE680B

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
22 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion of patients with atrial fibrillation and non atrial fibrillation in the trial Inclusion criteria for atrial fibrillation group: 1. Age >= 22 years old, gender not limited; 2. Diagnosed with atrial fibrillation and followed up by cardiovascular disease experts; 3. The 12 lead electrocardiograph showed atrial fibrillation characteristics during measurement. Inclusion criteria for non atrial fibrillation group: 1. Age >= 22 years old, gender not limited; 2. Individuals who have not been diagnosed with atrial fibrillation or other arrhythmias within the past year; 3. No indication of atrial fibrillation during measurement with a 12 lead electrocardiograph

Exclusion criteria

Exclusion criteria: 1. People who have difficulty measuring electrocardiogram or blood pressure due to skin reasons, such as rashes or wounds on the chest or arms; 2. Implanted pacemakers or defibrillators; 3. Individuals known to be allergic to any component of the testing equipment; 4. Individuals with a history of allergy to electrocardiogram electrodes; 5. Those who have poor compliance and are unable to complete follow-up as required by the protocol; 6.The researchers believe that there are other situations that are not suitable for participation in this experiment.

Design outcomes

Primary

MeasureTime frame
Sensitivity, specificity, and accuracy of single atrial fibrillation and triple atrial fibrillation measurement modes;Satisfaction with the equipment;

Secondary

MeasureTime frame
Operability and stability of instruments;

Countries

China

Contacts

Public ContactCheng Cheng

The First Affiliated Hospital of Anhui Medical University

chengcheng@ahmu.edu.cn+86 551 6292 3102

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026