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



Status:Completed
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:9/2/2018
Start Date:April 11, 2017
End Date:May 19, 2017

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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).


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
1
site
Walnut creek, California 94598
?
mi
from
Walnut creek, CA
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