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Electronic Blood Pressure Monitor for Atrial Fibrillation Detection

NCT06931288 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20000

Last updated 2025-04-17

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation (AF)

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.

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
125 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-06
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06931288 on ClinicalTrials.gov