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Evaluation of Blood Pressure Monitor With AFib Screening Feature

NCT05599308 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 574

Last updated 2023-04-28

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

OMRON blood pressure monitor with AFib screening feature

Blood pressure measurement by an oscillometric blood pressure monitor

DEVICE

Microlife WatchBP Home A

Blood pressure measurement by an oscillometric blood pressure monitor

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • Omron Healthcare Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-06
Primary Completion
2023-04-11
Completion
2023-04-11
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT05599308 on ClinicalTrials.gov