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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adults with New York Heart Association (NYHA) Class III Heart Failure (HF) who have experienced a heart failure hospitalization within the past 12 months.
Written informed consent obtained from subject
≥ 18 years of age
Diagnosis of NYHA Class III Heart Failure
At least 1 HF hospitalization within 12 months of Baseline visit
Subjects 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 subject is intolerant to beta blockers, ACE-I or ARB.
Subjects with a BMI ≤ 35. Subjects 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.
Subjects with pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the RHC)
Subjects willing and able to comply with the follow-up requirements of the study
Subjects with an active infection
Subjects with history of recurrent (> 1) pulmonary embolism or deep vein thrombosis
Subjects who, in the Investigator's opinion, are unable to tolerate a right heart catheterization
Subjects who have had a major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within 2 months of Baseline Visit
Subjects with Cardiac Resynchronization Device (CRT) implanted < 3 months prior to enrollment
Subjects with a Glomerular Filtration Rate (GFR) < 25 ml/min (obtained within 2 weeks of the baseline visit) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
Subjects with congenital heart disease or mechanical right heart valve(s)
Subjects likely to undergo heart transplantation or VAD within 6 months of baseline visit
Subjects with known coagulation disorders
Subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel (not applicable for subjects taking anti-coagulation therapy or other approved anti-platelets therapy).