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

NCT03126994 | Completed FDA Device

• 1 other identifier: 780-00033
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (3)

• Primary Objective: PWV Equivalence

  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.

  Day 1

• Pulse Rate Equivalence

  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.

  Day 1

• Body Weight Equivalence

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

  Day 1

Secondary Outcomes (5)

• Secondary Objective: BMI Equivalence

  Day 1

• Secondary Objective: Precision Analysis, PWV

  Day 1 or Day 2

• Secondary Objective: Precision Analysis, Pulse Rate

  Day 1 or Day 2

• Secondary Objective: Precision Analysis, Body Weight

  Day 1 or Day 2

• Secondary Objective: Precision Analysis, BMI

  Day 1 or Day 2

Other Outcomes (2)

• Exploratory Analysis: Impact of Strong Vasoactive Drugs on PWV Equivalence

  Day 1

• Exploratory Analysis: Impact of BMI on PWV Equivalence

  Day 1

Study Arms (1)

PhysioWave Cardiovascular Analyzer

EXPERIMENTAL

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.

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

Interventions

PhysioWave Cardiovascular Analyzer DEVICE

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

PhysioWave Cardiovascular Analyzer

AtCor XCEL PWA & PWV DEVICE

Measurement of Pulse Wave Velocity and Pulse Rate

PhysioWave Cardiovascular Analyzer

Detecto SOLO DEVICE

Measurement of Body Weight and BMI

PhysioWave Cardiovascular Analyzer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• PhysioWave, Inc.: lead

Study Sites (1)

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

MeSH Terms

Interventions

Pulse Wave Analysis

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective validation study to evaluate PWV, PR, and BW accuracy in a sample of subjects representing the US general adult population.

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 25, 2017
• Study Start: April 11, 2017
• Primary Completion: May 19, 2017
• Study Completion: May 19, 2017
• Last Updated: August 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)