CardioMEMS HF System Post Approval Study

Inclusion Criteria:

- Diagnosis of NYHA class III heart failure

- At least 1 heart failure hospitalization within previous 12 months

- Patients with reduced LVEF heart failure should be receiving a beta blocker for 3
months and an ACE-I or ARB for one month unless in the investigator's opinion, the
patient is intolerant to beta blockers, ACE-I or ARB

- BMI ≤ 35. Patients with BMI >35 will require their chest circumference to be measured
at the axillary level. If > 65 inches the patient will not be eligible for the study.

- Pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the
right heart catheterization)

Exclusion Criteria:

- Active infection

- History of recurrent (> 1) pulmonary embolism or deep vein thrombosis

- Inability to tolerate a right heart catheterization

- A major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke,
etc.) within previous 2 months

- Cardiac resynchronization device (CRT) implanted within previous 3 months

- Glomerular Filtration Rate (GFR) < 25 ml/min (obtained within 2 weeks of implant) who
are non-responsive to diuretic therapy or who are on chronic renal dialysis

- Congenital heart disease or mechanical right heart valve

- Likely to undergo heart transplantation or VAD within the next 6 months

- Known coagulation disorders

- Hypersensitivity or allergy to aspirin, and/or clopidogrel