Comparison of Cuff-Less Wrist Wearable Blood Pressure Device to Cuff Based Blood Pressure Measuring Devices
Recruiting · NCT04835857 · Observational (researchers observe without assigning treatment) · Lead sponsor: Dynocardia, Inc
View the official record on ClinicalTrials.gov →Interventions studied
Auscultatory cuffOscillometric BP DeviceViTrack
What this trial is about
(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.
Who can take part
Age range
18 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
1 location listed across 1 US state.
- Dynocardia Inc - Newton, Massachusetts, United States