NCT04835857Recruiting
Comparison of Cuff-Less Wrist Wearable Blood Pressure Device to Cuff Based Blood Pressure Measuring Devices
Dynocardia, Inc
Start Date
1/1/2021
Completion Date
11/30/2026
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.
Detailed 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.
Eligibility Criteria
Age Range: 18 years to 90 years
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.
Interventions
DEVICE
ViTrack
DEVICE
Oscillometric BP Device
DEVICE
Auscultatory cuff
Conditions
HypertensionHealthy
Locations
Dynocardia Inc
Newton, Massachusetts 02459
United States