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OpenTrials
Completed

NCT Number: NCT03126994

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

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).

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Key information

Conditions

Cardiovascular Risk Factor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PhysioWave Cardiovascular Analyzer

Device

Measurement of Pulse Wave Velocity, Pulse Rate, Body Weight and BMI

AtCor XCEL PWA & PWV

Device

Measurement of Pulse Wave Velocity and Pulse Rate

Detecto SOLO

Device

Measurement of Body Weight and BMI

Primary outcomes

  1. Primary Objective: PWV Equivalence

    Time frame: Day 1

    The first primary study objective is to demonstrate equivalency when measuring: pulse wave velocity (PWV) (in m/s) between the PhysioWave Cardiovascular Analyzer and AtCor Medical SphygmoCor® XCEL PWA & PWV.

  2. Pulse Rate Equivalence

    Time frame: Day 1

    The second primary study objective is to demonstrate equivalency when measuring: pulse rate (in bpm) between the PhysioWave Cardiovascular Analyzer and AtCor Medical SphygmoCor® XCEL PWA & PWV.

  3. Body Weight Equivalence

    Time frame: Day 1

    The third primary study objective is to demonstrate equivalency when measuring body weight (in kg) between the PhysioWave Cardiovascular Analyzer and the Detecto Solo.

Secondary outcomes

  1. Secondary Objective: BMI Equivalence

    Time frame: Day 1

    Demonstrate equivalency when measuring Body Mass Index (BMI) (in kg/m^2) between the PhysioWave Cardiovascular Analyzer and the Detecto Solo

  2. Secondary Objective: Precision Analysis, PWV

    Time frame: Day 1 or Day 2

    Evaluate the precision of PWV measurements (in m/s) due to the sources of variation in measurements in the PhysioWave Cardiovascular Analyzer and AtCor Medical SphygmoCor® XCEL PWA & PWV. Sources of variation to be assessed include between-replicates, between-device, between-operator, and total (overall).

  3. Secondary Objective: Precision Analysis, Pulse Rate

    Time frame: Day 1 or Day 2

    Evaluate the precision of pulse rate measurements (in bpm) due to the sources of variation in measurements in the PhysioWave Cardiovascular Analyzer and AtCor Medical SphygmoCor® XCEL PWA & PWV. Sources of variation to be assessed include between-replicates, between-device, between-operator, and total (overall).

  4. Secondary Objective: Precision Analysis, Body Weight

    Time frame: Day 1 or Day 2

    Evaluate the precision of body weight measurements (in kg) due to the sources of variation in measurements in the PhysioWave Cardiovascular Analyzer and the Detecto Solo. Sources of variation to be assessed include between-replicates, between-device, between-operator, and total (overall).

  5. Secondary Objective: Precision Analysis, BMI

    Time frame: Day 1 or Day 2

    Evaluate the precision of BMI measurements (in kg/m^2) due to the sources of variation in measurements in the PhysioWave Cardiovascular Analyzer and the Detecto Solo. Sources of variation to be assessed include between-replicates, between-device, between-operator, and total (overall).

Other outcomes

  1. Exploratory Analysis: Impact of Strong Vasoactive Drugs on PWV Equivalence

    Time frame: Day 1

    An exploratory analysis will be conducted to evaluate any effects of strong vasoactive drugs, such as those used to control high blood pressure, on equivalency when measuring: pulse wave velocity (PWV) (in m/s) between the PhysioWave Cardiovascular Analyzer and AtCor Medical SphygmoCor® XCEL PWA & PWV.

  2. Exploratory Analysis: Impact of BMI on PWV Equivalence

    Time frame: Day 1

    An exploratory analysis will be conducted to evaluate any effect(s) of BMI (in kg/m^2) on equivalency when measuring: pulse wave velocity (PWV) (in m/s) between the PhysioWave Cardiovascular Analyzer and AtCor Medical SphygmoCor® XCEL PWA & PWV.

Sponsors and collaborators

Lead sponsor

PhysioWave, Inc.

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 25, 2017
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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