SIRONA 2 Trial Heart Failure NYHA Class III

The study objectives are:

• To establish that the Cordella PA Sensor can be safely delivered, deployed, and remain stable within the target pulmonary artery (PA) segment through 30 days post-implant.
• To compare Cordella PA Sensor System pressure measurements with fluid-filled catheter PA pressure measurements obtained by standard right heart catheterization (RHC) at 90 days post implant.

Inclusion criteria

• Subject has given written informed consent
• Male or female, at least 18 years of age
• Diagnosis of HF ≥ 6 months with either preserved or reduced left ventricular ejection fraction (LVEF) and NYHA Class III HF at the time of Screening
• HF related hospitalization, HF treatment in a hospital day-care setting, or unplanned outpatient clinic HF visit within 12 months prior to consent and/or increase of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or Brain Natriuretic Peptide (BNP)) at time of Screening defined as:

• Subjects with LVEF ≤ 40%: NT-proBNP ≥ 1000 pg/mL (or BNP ≥ 250 pg/mL).
• Subjects with LVEF > 40%: NT-proBNP ≥ 700 pg/mL (or BNP ≥ 175 pg/mL). Thresholds for NT-proBNP and BNP (for both LVEF ≤ 40% and LVEF > 40%) will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2
• Subjects must be receiving appropriate medical management of HF for 3 months prior to Screening and clinically stable for at least 1 month prior to study entry
• Subjects who are physically able to hold the myCordella™ Patient Reader unit (approximate weight 600g) against the ventral thoracic surface for up to 2 minutes per day while in a seated position, as well as dock and undock the myCordella™ Patient Reader
• Subjects with sufficient eyesight, hearing, and mental capacity to respond to the myCordella™ Patient Reader's audio/visual cues and operate the myCordella™ Patient Reader
• Subject has sufficient Cellular and/or Wi- Fi Internet coverage at home
• Subject agrees to return to the treating Investigator for all scheduled follow up visits and can return to the hospital for follow up

Exclusion criteria

• Subjects with primary pulmonary hypertension
• Subjects with an active infection at the Cordella PA Sensor Implant Visit
• Subjects with history of pulmonary embolism or deep vein thrombosis
• Subjects who have had a major cardiovascular event (e.g., myocardial infarction, stroke) within 2 months of the Screening Visit
• Subjects whereby RHC is contraindicated
• Implanted with a Cardiac Rhythm Management (CRM) Device (Internal Cardiac Defibrillator (ICD) or pacemaker) or Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) less than 90 days prior to screening visit
• Any major surgery within 30 days of the Sensor Implant Visit.
• Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min or who are on chronic renal dialysis
• Specific liver enzymes [Aspartate Aminotransferase (AST) (SGOT), and Alanine Aminotransferase (ALT) (SGPT) >3 times the upper limit of normal
• Received or are likely to receive an advanced therapy (e.g., mechanical circulatory support or lung or heart transplant) in the next 12 months
• Subjects with congenital heart disease or mechanical/tissue right heart valve(s)
• Subjects with known coagulation disorders
• Subjects with a hypersensitivity or allergy to platelet aggregation inhibitors including aspirin, clopidogrel, prasugrel, and ticagrelor; or patients unable to take dual antiplatelet or anticoagulants for one- month post implant
• Known history of life threatening allergy to contrast dye
• Subjects who are pregnant or breastfeeding
• Subjects who are unwilling or deemed by the Investigator to be unwilling to comply with the study protocol, or subjects with a history of non-compliance
• Severe illness, other than heart disease, which would limit survival to <1 year
• Subjects whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study
• Subjects enrolled in another investigational trial with an active Treatment Arm
• Subject who is in custody by order of an authority or a court of law
• Unrepaired severe valvular disease
• Subjects with an inferior vena cava (IVC) filter