Prospective, Single-Center, Non-Randomized Study of the PhysioWave™ Cardiovascular Analyzer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cardiovascular Risk Factor
- Sponsor
- PhysioWave, Inc.
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Primary Objective: PWV Equivalence
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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).
Investigators
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.
Outcomes
Primary Outcomes
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.
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.
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
- Secondary Objective: Precision Analysis, Pulse Rate(Day 1 or Day 2)
- Secondary Objective: BMI Equivalence(Day 1)
- Secondary Objective: Precision Analysis, PWV(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)