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Clinical Trials/NCT07442175
NCT07442175
Recruiting
Not Applicable

Blood Pressure Monitor (TH-75) Atrial Fibrillation Detection Function Clinical Trial

Andon Health Co., Ltd1 site in 1 country392 target enrollmentStarted: February 9, 2026Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
392
Locations
1
Primary Endpoint
Accuracy of atrial fibrillation detection by the TH-75 blood pressure monitor, assessed against the prespecified acceptance criteria.

Overview

Brief Summary

This study evaluates the accuracy of a blood pressure monitor in detecting atrial fibrillation by comparing its results with a standard diagnostic method.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
22 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Subjects use Blood Pressure Monitor (TH-75) and ECG

Outcomes

Primary Outcomes

Accuracy of atrial fibrillation detection by the TH-75 blood pressure monitor, assessed against the prespecified acceptance criteria.

Time Frame: Baseline

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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