RecruitingNCT06560034

VicorderCS NIBP Validation Study to Review The Ability to Capture Blood Pressure Measurements

VicorderCS NIBP Validation Study to Assess Its Ability to Capture Blood Pressure Measurements

Sponsor

80 Beats Medical

Enrollment

120 participants

Start Date

Aug 15, 2024

Study Type

OBSERVATIONAL

Conditions

Cardiovascular Diseases Hypertension Blood Pressure

Summary

80 Beats Medical introduces the VicorderCS, the next generation of our Vicorder technology designed to manage hypertension and cardiovascular risks. This advanced diagnostic equipment offers non-invasive collection and computation of a plethora of cardiovascular markers. It is faster, easier to use, and more portable than its predecessor, with enhanced connectivity options for extended marker collection and analysis. These markers enable early diagnosis of cardiovascular disease, ensuring positive patient outcomes. With a strong foundation in numerous published clinical studies, the VicorderCS enhances data collection and analysis capabilities, empowering the research community in developing new drugs and therapeutics. This validation study is purposed to evaluate one of the physiological parameters that is measured by the VicorderCS system, which is Non-invasive Blood Pressure (NIBP) via the common oscillometric cuff-based method.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Any gender, in good general health
Must be 18 years old or older, inclusive at enrollment
Must be willing to provide blood pressure measurement
Must be able to read, understand, and willingly sign an Informed Consent Form
Must be able to read, speak and understand English
Must be available to attend one study visit at: please specify exact location.

Exclusion Criteria4

Excluding subjects with significantly irregular heart rhythm (e.g. Bigeminy, trigeminy, isolated ventricular premature beat (VPB), atrial fibrillation) or are pregnant
No active email address
Non-English or Spanish- speaking
Unable to read in English.

Interventions

DEVICEVicorderCS

1. Vascular Sensor (VCS-VAS-1000) measurement device used with accessories (cuffs and tubes) connected to the device; 2. Data Station (VCS-DAT-1000) for data collection and analysis