Evaluation of Blood Pressure Monitor With AFib Screening Feature

Status Completed

Clinical Trial Summary

This study aims to evaluate the safety and effectiveness of the Omron blood pressure (BP) monitor with AFib screening feature. The primary outcome is to validate if the Omron BP-monitor with AFib screening feature meets acceptance criteria in sensitivity and specificity. The acceptance criteria of the sensitivity and specificity should be statistically non-inferior to those of primary predicate device.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Atrial Fibrillation

Clinical Trial Details

NCT number	NCT05599308
Study type	Interventional
Source	Omron Healthcare Co., Ltd.
Contact
Status	Completed
Phase	N/A
Start date	September 6, 2022
Completion date	April 11, 2023

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