PROACTIVE-HF IDE Trial Heart Failure NYHA Class III

Exclusion Criteria

• •1. Intolerance to all neuro-hormonal antagonists (i.e., intolerance to ACE-I, ARB, ARNI, and beta-blockers) due to hypotension or renal dysfunction
• •2. ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)
• •3. Subjects with history of recurrent pulmonary embolism ( ≥2 episodes within 5 years prior to Screening Visit) and/or deep vein thrombosis (\< 3 month prior to Screening Visit)
• •4. Subjects who have had a major cardiovascular (CV) event (e.g. myocardial infarction, stroke) within 3 months of the Screening Visit
• •5. Unrepaired severe valvular disease
• •6. Subjects with significant congenital heart disease that has not been repaired and would prevent implantation of the Cordella PA sensor or mechanical/tissue right heart valve(s)
• •7. Subjects with known coagulation disorders
• •8. 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
• •9. Known history of life threatening allergy to contrast dye
• •10. Subjects whereby RHC is contraindicated
• •11. Subjects with an active infection at the Sensor Implant Visit
• •12. Subjects with a Glomerular Filtration Rate (GFR) \<25 ml/min or who are on chronic renal dialysis
• •13. Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to screening visit
• •14. Received or are likely to receive an advanced therapy (e.g. mechanical circulatory support or lung or heart transplant) in the next 12 months
• •15. Subjects who are pregnant or breastfeeding
• •16. 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
• •17. Severe illness, other than heart disease, which would limit survival to \<1 year
• •18. Subjects whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study
• •19. Subjects enrolled in another investigational trial with an active treatment arm
• •20. Subject who is in custody by order of an authority or a court of law