Validation of Optical Device for Aortic Pulse Wave Velocity Measurement

VitalSines

Status: Not yet enrolling

Conditions: Aortic Pulse Wave Velocity

Treatments: Device: System & Method for Monitoring Aortic Pulse Wave Velocity & Blood Pressure

Study type: Observational

Funder types: Industry

Identifiers

NCT05400421

OBA-MAPWV

Details and patient eligibility

About

Existing techniques available for capturing reliable aortic pulse wave velocity measurements and estimating aortic stiffness are costly and require technical expertise. The purpose of this research is to investigate an oximeter device performance as a stand-alone aortic pulse wave velocity (PWV) measurement instrument. By validating this device and its measurements against the gold-standard method of carotid-femoral readings, we aim to demonstrate that the proposed method is an comparably effective in terms of the metrics (Mean difference, standard deviation, correlation, etc.) outlined by the Artery Society Guidelines.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Exclusion criteria

• History of cardiovascular disease
• Not in sinus rhythm/arrhythmia
• Pacemaker
• Impalpable arterial pulse
• Use of blood pressure medication
• Systolic blood pressure > 140
• Use of vasoactive medication
• Use of cholesterol medication
• Diabetes diagnosis
• Smokers
• BMI > 30 kg/m2
• Pregnancy

Trial design

180 participants in 2 patient groups

Device Calibration & Algorithm Training

Description:

The data obtained from this group will be used to a) quantify the relationship between PWV measured at the groin versus the thigh for less intrusive future piezo sensor placement and b) train the proposed device for the next cohort.

Treatment:

Device: System & Method for Monitoring Aortic Pulse Wave Velocity & Blood Pressure

Device & Algorithm Testing

Description:

The gold-standard and new device values will be collected from this group to validate the previously trained system.

Treatment:

Device: System & Method for Monitoring Aortic Pulse Wave Velocity & Blood Pressure