Prospective, Single-Center, Non-Randomized Study of the PhysioWave™ Cardiovascular Analyzer

Completed · Not applicable

Conditions studied: Cardiovascular Risk Factor

In brief

This is a prospective, single-center, non-randomized validation study being conducted under a non-significant risk study design with the primary aim to evaluate PWV, PR, and BW accuracy in a sample of subjects representative of the US general adult population. The primary study objective is to demonstrate equivalency when measuring: Pulse Wave Velocity (PWV) and Pulse Rate (PR) between the PhysioWave Cardiovascular Analyzer (CA) and AtCor Medical SphygmoCor® XCEL PWA \& PWV (XCEL), and Body Weight (BW) between the CA and the Detecto Solo Digital Healthcare Scale (Detecto).

Key facts

Study ID

NCT03126994

Run by

PhysioWave, Inc.

People needed

160

Starts

2017-04-11

Expected to finish

2017-05-19

Last updated by the study team

2018-08-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects >18 years old
• Subject signs a written Informed Consent form to participate in the study, prior to any study procedures
• Subgroup Inclusion Criteria
• Subject has been taking ACE Inhibitors or Angiotensin Receptor Blockers for at least 30 days

You may not qualify if…

• Known significant carotid or femoral artery stenosis
• Non-palpable (non-detectable) arterial pulse at the sites of measurements
• Pacemaker, defibrillator, or other cardiac stimulator
• Erratic, accelerated or mechanically controlled irregular heart rhythm, or an arrhythmia
• History of cardiac valve disorder or cardiac valve disease
• History of venous disease, including venous insufficiency or deep vein thrombosis
• History of peripheral artery disease
• Requirement for supplemental oxygen
• Neuromuscular disorders that cause shaking or tremors (such as Parkinson's disease or Multiple Sclerosis), or other disease or condition affecting balance
• Amputation or malformation of any limb or extremity (foot, leg, or arm) which would impede the placement of blood pressure cuffs or standing on the scale with two feet.
• Known or suspected pregnancy
• Inability to provide informed consent
• Mental incompetence or a prisoner status
• Current participation in a clinical trial of another investigational drug or device in which the study endpoint has not been met
• BMI > 40
• Subjects > 400 lbs
• Subjects on strong vasoactive drugs, such as those used to control high blood pressure, for <30 days
• Blood loss or blood donation of ˃ 550 mL within 30 days before study procedure

Where it is running

• Diablo Clinical Research — Walnut Creek, California, United States

Full record on ClinicalTrials.gov

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