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

Cardiovascular Risk Factor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03126994
• Other study ID #: 780-00033
• Status: Completed
• Phase: N/A
• Start date: April 11, 2017
• Est. completion date: May 19, 2017

Study information

• Verified date: August 2018
• Source: PhysioWave, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 19, 2017
• Est. primary completion date: May 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

Device:
• PhysioWave Cardiovascular Analyzer
Measurement of Pulse Wave Velocity, Pulse Rate, Body Weight and BMI
• AtCor XCEL PWA & PWV
Measurement of Pulse Wave Velocity and Pulse Rate
• Detecto SOLO
Measurement of Body Weight and BMI

Locations

Country	Name	City	State
United States	Diablo Clinical Research	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
PhysioWave, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Analysis: Impact of Strong Vasoactive Drugs on PWV Equivalence	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.	Day 1
Other	Exploratory Analysis: Impact of BMI on PWV Equivalence	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.	Day 1
Primary	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
Primary	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
Primary	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	Secondary Objective: BMI Equivalence	Demonstrate equivalency when measuring Body Mass Index (BMI) (in kg/m^2) between the PhysioWave Cardiovascular Analyzer and the Detecto Solo	Day 1
Secondary	Secondary Objective: Precision Analysis, PWV	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).	Day 1 or Day 2
Secondary	Secondary Objective: Precision Analysis, Pulse Rate	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).	Day 1 or Day 2
Secondary	Secondary Objective: Precision Analysis, Body Weight	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).	Day 1 or Day 2
Secondary	Secondary Objective: Precision Analysis, BMI	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).	Day 1 or Day 2