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

Launched by DYNOCARDIA, INC · Apr 5, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new blood pressure measuring device that doesn't require a traditional cuff, which is usually wrapped around the arm. Instead, this device is a wrist wearable that measures blood pressure at the radial artery using a technology called ViTrack, developed by Dynocardia. The goal is to see how well this cuff-less device works compared to standard cuff-based blood pressure machines in healthy volunteers who might have normal or high blood pressure.

To participate in this study, you need to be at least 18 years old and willing to give your consent to be part of the trial. The researchers are looking for a balanced number of men and women to ensure that both sexes are represented. However, some people may not be eligible, such as those with specific health conditions or previous injuries affecting the wrist. If you join, you can expect to have your blood pressure measured with both the new device and the traditional one, helping researchers understand how effective this new method is.

Gender

ALL

Eligibility criteria

• 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.