Blood Pressure Monitor (TH-75) Atrial Fibrillation Detect... | NCT07442175

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

NCT07442175

Sponsor

Andon Health Co., Ltd

Status

Recruiting

Last Update Posted

Mar 2, 2026Actual

Enrollment

392Estimated

Phase

Not provided

Conditions

Atrial Fibrillation (AF)

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 9, 2026Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Jul 30, 2026Estimated

First Submitted Date

Feb 24, 2026

First Submission Date that Met QC Criteria

Feb 24, 2026

First Posted Date

Mar 2, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2026

Last Update Posted Date

Mar 2, 2026Actual

Name	Class
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

392Estimated

Label	Type	Description	Intervention Names
Subjects use Blood Pressure Monitor (TH-75) and ECG

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jing Li	Contact	022-87611660		lijing@jiuan.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine	Recruiting	Tianjin	Tianjin Municipality	300381	China

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided