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

PhysioWave

Status: Completed

Conditions: Cardiovascular Risk Factor

Treatments: Device: AtCor XCEL PWA & PWV; Device: PhysioWave Cardiovascular Analyzer; Device: Detecto SOLO

Study type: Interventional

Funder types: Industry

Identifiers

NCT03126994

780-00033

Details and patient eligibility

About

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).

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

PhysioWave Cardiovascular Analyzer

Experimental group

Description:

The Experimental Device is the PhysioWave Cardiovascular Analyzer, which will be used to measure Pulse Wave Velocity, Pulse Rate, Body Weight, and BMI. This will be compared to FDA-cleared devices to determine equivalence: AtCor XCEL PWA \& PWV to measure Pulse Wave Velocity and Pulse rate, and Detecto SOLO to measure Body Weight and BMI.

Treatment:

Device: Detecto SOLO

Device: PhysioWave Cardiovascular Analyzer

Device: AtCor XCEL PWA & PWV