Echosens
This is a pivotal, global, prospective, cross-sectional, multicentric clinical investigation designed to explore a non-invasive, reliable alternative to invasive, catheter-based hemodynamic assessments, which are associated with procedural risks and limited applicability in certain participant populations.
CHF, as defined by the American College of Cardiology and the American Heart Association, is "a complex clinical syndrome that results from any structural or functional impairment of ventricular filling or ejection of blood." These patients will often develop congestion that may require urgent hospitalization, especially if pulmonary congestion is present. However, congestion can be difficult to assess, especially when symptoms are mild, or in patients nearing discharge from an HF hospitalization.8 Increased cardiac filling pressures, including the CVP, often silently precede the appearance of…
Inclusion Criteria: 1. Have read, understood, and signed the informed consent form (ICF) 2. Be ≥18 years of age at the time of screening 3. Have suspected or diagnosed acute or chronic HF and be scheduled to undergo right-sided cardiac catheterization Exclusion Criteria: 1. Inability to consent 2. Chronic liver disease (self-reported alcohol use \>14 drinks/week in females and \>21 drinks/week in males), positive hepatitis C virus serology, positive hepatitis B surface antigen, autoimmune hepatitis, hemochromatosis, or cholestatic disease) 3. BMI \>40 kg/m2 4. Fontan-type circulation 5. Asc…
At Day 0: 1 FibroScan examination to collect Liver Stiffness Measurement (LSM)
at Day 0: Right-sided Heart Catheterization (RHC) to measure Central Venous Pressure (CVP)
at Day 0 assessment of cardiac function
At Day0: To assess baseline organ function that may impact participant safety, and blood samples for clinical laboratory tests