Recruiting
Comparison of Cuff-Less Wrist Wearable Blood Pressure Device to Cuff Based Blood Pressure Measuring Devices
(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.
ClinicalTrials.gov IDNCT04835857
PhaseNot Applicable
Enrollment91
SponsorDynocardia, Inc
Age18 Years
SexALL
Conditions studied
Hypertension, Healthy
About this study
(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.
Interventions
- Device: ViTrack — ViTrack is a continuous non-invasive wearable blood pressure cuff.
- Device: Oscillometric BP Device — Oscillometric blood pressure measurement is the standard of care for measuring blood pressure in outpatient / home settings.
- Device: Auscultatory cuff — The auscultatory method is the gold standard for clinical blood pressure measurement. A brachial cuff is mounted and a trained healthcare provider uses a sphygmomanometer and listens for the Korotkoff sounds using a stethoscope to measure blood pressure.
Primary outcomes
- Comparison of Diastolic Blood Pressure (up to 30 minutes)
- Comparison of Systolic Blood Pressure (up to 30 minutes)
Eligibility information
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.
Study locations
- Dynocardia Inc, Newton, Massachusetts 02459 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.