Comparison of Cuff-Less Wrist Wearable Blood Pressure Device to Cuff Based Blood Pressure Measuring Devices

  • STATUS
    Recruiting
  • End date
    Mar 1, 2022
  • participants needed
    91
  • sponsor
    Dynocardia, Inc
Updated on 28 April 2021

Summary

(1) To compare cuff-less wrist wearable radial artery blood pressure measurements utilizing ViTrack(developed by Dynocardia) to the cuff based commercially available blood pressure device, in healthy volunteers with normal or high blood pressure.

Description

(1) The ViTrack is strapped over the radial artery at the wrist. The ViTrack blood pressure cuff will be utilized to obtain blood pressure(BP) readings in the volunteers with normal or high blood pressure. The readings from the ViTrack will be compared with the readings of a cuff-based, commercially available BP measuring device placed on the same arm.

Details
Condition Vascular Diseases, Hypertension, healthy, Diabetes and Hypertension, High Blood Pressure (Hypertension), High Blood Pressure (Hypertension - Pediatric), Elevated Blood Pressure, high blood pressure, arterial hypertension, Compare the ViTrack With a Commercially Available Cuff-based BP Device, Compare the ViTrack With a Commercially Available Cuff-based BP Device
Treatment ViTrack, Oscillometric BP Device, Auscultatory cuff
Clinical Study IdentifierNCT04835857
SponsorDynocardia, Inc
Last Modified on28 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Health volunteers 18 years and above; equal numbers of males and females to address Sex As a Biological Variable (SABV); and in sinus rhythm
Agree to commit to participate in the current protocol
Provide written informed consent prior to any study procedures being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read)

Exclusion Criteria

Unable or unwilling to provide informed consent
Any other condition that would increase the risk of participation in the study in the opinion of the site Investigator
A difference of >10 mm Hg in left versus right arm oscillometric systolic BP
Upper extremity arteriovenous hemodialysis shunt
Wrist distortion or pain from arthritis
Prior trauma or surgery at the radial artery monitoring site
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