NCT07442175

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
392

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress74%
Feb 2026Jul 2026

Study Start

First participant enrolled

February 9, 2026

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 24, 2026

Last Update Submit

February 24, 2026

Conditions

Atrial Fibrillation (AF)

Outcome Measures

Primary Outcomes (1)

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

    Baseline

Study Arms (1)

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

Eligibility Criteria

Age22 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adults aged 22 years or older with an arm circumference between 22 cm and 42 cm, including individuals diagnosed with atrial fibrillation and individuals without a prior diagnosis of atrial fibrillation, who are able to undergo blood pressure and ECG measurements.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, 300381, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Jing Li

CONTACT

022-87611660lijing@jiuan.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2026

First Posted

March 2, 2026

Study Start

February 9, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

March 2, 2026

Record last verified: 2026-02

Locations

CN(1)