TH-75 blood pressure monitor for detecting atrial fibrillation
Blood Pressure Monitor (TH-75) Atrial Fibrillation Detection Function Clinical Trial
We will test whether the TH-75 blood pressure monitor can detect atrial fibrillation in adults with or without a prior AF diagnosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 392 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Andon Health Co., Ltd Industry-sponsored |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT07442175 on ClinicalTrials.gov |
What this trial studies
This observational study compares readings from the TH-75 blood pressure monitor with a standard diagnostic method (ECG) to measure the device's accuracy for atrial fibrillation detection. Adults aged 22 and older with an arm circumference of 22-42 cm, both people diagnosed with AF and those without known AF, will have simultaneous device and ECG measurements. Participants who are pregnant, have an implanted pacemaker or defibrillator, or cannot cooperate with measurements will be excluded. The trial is conducted at the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine in Tianjin, China.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 or older with arm circumference 22-42 cm who can cooperate with blood pressure and ECG measurements, whether they have a prior AF diagnosis or not.
Not a fit: Patients with implanted pacemakers or defibrillators, pregnant people, those with arm circumference outside 22-42 cm, or those unable to cooperate with measurements are unlikely to benefit.
Why it matters
Potential benefit: If accurate, the TH-75 could enable easier routine blood pressure checks to spot atrial fibrillation sooner and prompt timely care.
How similar studies have performed: Previous studies of blood-pressure devices with AF-detection algorithms have shown promising but variable accuracy, so device-specific testing is needed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Atrial Fibrillation (AF): * Age ≥ 22 years; * Arm circumference between 22 cm and 42 cm; * Diagnosed with atrial fibrillation by a qualified medical institution. Non-Atrial Fibrillation: * Age ≥ 22 years; * Arm circumference between 22 cm and 42 cm; * No prior diagnosis of atrial fibrillation. Exclusion Criteria: * Pregnant women * Presence of an implanted cardiac pacemaker and/or defibrillator * Inability to cooperate with blood pressure measurement or ECG assessment * Any condition that, in the opinion of the investigator, makes the participant unsuitable for participation in this clinical study
Where this trial is running
Tianjin, Tianjin Municipality
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jing Li
- Email: lijing@jiuan.com
- Phone: 022-87611660
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.