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NCT06931288
NA

Electronic Blood Pressure Monitor for Atrial Fibrillation Detection

Sponsor: Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

Summary

Study name: Study on the Effectiveness of Atrial Fibrillation Screening Using Electronic Blood Pressure Monitor with Atrial Fibrillation Detection Function Objective: This study compares an electronic blood pressure monitor (BP77A1T, Omron Healthcare, Kyoto, Japan) with single-lead electrocardiography for atrial fibrillation detection in an elderly Chinese population. Study design: This study is a cluster-randomized and controlled trial. Study population: Men and women aged over 60 years meeting the inclusion/exclusion criteria. Randomization and treatment: Eligible centers as clusters will be randomly assigned to either the single-lead electrocardiography group or the electronic blood pressure monitor group for atrial fibrillation detection. Sample size: About 50 centers, at least 20,000 participants. Timeline: Participants enrollment are expected to be performed from May 2025 to July 2026. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

Official title: Study on the Effectiveness of Atrial Fibrillation Screening Using Electronic Blood Pressure Monitor With Atrial Fibrillation Detection Function

Key Details

Gender

All

Age Range

60 Years - 125 Years

Study Type

INTERVENTIONAL

Enrollment

20000

Start Date

2025-05-06

Completion Date

2026-07-31

Last Updated

2025-04-17

Healthy Volunteers

Yes

Interventions

DEVICE

Blood pressure monitor

In the trial group, atrial fibrillation screening will be integrated into blood pressure measurements using the BP77A1T electronic blood pressure monitor (Omron Healthcare, Kyoto, Japan).

DEVICE

Single-lead ECG

In the control group, a single-lead ECG will be recorded for 30s with a handheld ECG for atrial fibrillation detection. Each ECG rhythm strip will be reviewed and analyzed by a cardiologist from the research team.

Locations (1)

Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai 200025

Shanghai, Shanghai Municipality, China