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 |
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).
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
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