Clinical trial NCT03126994: Prospective, Single-Center, Non-Randomized Study of the PhysioWave™ Cardiovascular Analyzer
Official title: Prospective, Single-Center, Non-Randomized Study of the PhysioWave™ Cardiovascular Analyzer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Lead sponsor: PhysioWave, Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-25
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective validation study to evaluate PWV, PR, and BW accuracy in a sample of subjects representing the US general adult population.
Primary purpose: OTHER

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).


Eligibility criteria: 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

Primary outcomes:
measure: Primary Objective: PWV Equivalence
timeFrame: Day 1
measure: Pulse Rate Equivalence
timeFrame: Day 1
measure: Body Weight Equivalence
timeFrame: Day 1
Secondary outcomes:
measure: Secondary Objective: BMI Equivalence
timeFrame: Day 1
measure: Secondary Objective: Precision Analysis, PWV
timeFrame: Day 1 or Day 2
measure: Secondary Objective: Precision Analysis, Pulse Rate
timeFrame: Day 1 or Day 2
measure: Secondary Objective: Precision Analysis, Body Weight
timeFrame: Day 1 or Day 2
measure: Secondary Objective: Precision Analysis, BMI
timeFrame: Day 1 or Day 2
Other outcomes:
measure: Exploratory Analysis: Impact of Strong Vasoactive Drugs on PWV Equivalence
timeFrame: Day 1
measure: Exploratory Analysis: Impact of BMI on PWV Equivalence
timeFrame: Day 1
Locations:
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
Study officials:
References: