CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients

Inclusion Criteria:

Diagnosis of HF ≥ 3 months, with either preserved or reduced LVEF
Diagnosis of NYHA Class III HF (historical assessment documented at screening visit)
Subjects with reduced LVEF must be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the subject is intolerant to beta blockers, ACE-I or ARB. Beta blockers and ACE-I (or ARB) doses should be stable for one month prior to study entry.
At least 1 HF hospitalization within 12 months of Screening Visit
Subjects with pulmonary artery branch diameter sized between 7mm and 15mm (implanted vessel)

Exclusion Criteria:

Subjects with history of recurrent (> 1) pulmonary embolism or deep vein thrombosis
Subjects, in the Investigator's opinion, unable to tolerate a right heart catheterization
Subjects who have had a major cardiovascular event (e.g., myocardial infarction, stroke) within 2 months of Screening Visit
Subjects with Cardiac Resynchronization Device (CRT) implanted ≤ 3 months prior to enrollment
Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min who are non-responsive to diuretic therapy or who are on chronic renal dialysis
Subjects likely to undergo heart transplantation within 6 months of Screening Visit
Subjects with congenital heart disease or mechanical right heart valve(s)
Subjects with known coagulation disorders
Subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel