Validation of Optical Device for Aortic Pulse Wave Velocity Measurement

Validation of Photoplethysmography Device for the Measurement of Aortic Pulse Wave Velocity Against Carotid-Femoral Values From Piezoelectric Sensors

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05400421

Enrollment

180

Registered

2022-06-01

Start date

2022-06-30

Completion date

2022-07-31

Last updated

2022-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Pulse Wave Velocity

Keywords

aortic pulse wave velocity, plethysmography

Brief summary

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.

Interventions

DEVICESystem & Method for Monitoring Aortic Pulse Wave Velocity & Blood Pressure

Carotid-femoral aortic pulse wave velocity will be compared against values collected from the oximeter system. The former is assessed by placing piezoelectric pressure sensors at three locations: the right common carotid artery, the right common femoral artery (groin), and the right superficial femoral artery (thigh). The oximeter will be secured on the right index finger. Simultaneous data collection will occur for both methods, with each trail lasting 60 seconds.

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Aortic Pulse Wave Velocity	6 measurements per subject, each lasting 60 seconds	The speed at which a single pulse/heart beat propagates down the aorta.

Contacts

Primary ContactJess Goodman, M.D.

jess@goiheart.com416-670-9306

Backup ContactClare Wei

c53wei@uwaterloo.ca289-338-5669

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026