CardioMEMS HF System OUS Post Market Study

Korábbi kezelés

• Subjects with Cardiac Resynchronization Device (CRT) implanted < 3 months prior to enrollment

Más betegség

• 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 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

Laborértékek

• 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 a hypersensitivity or allergy to aspirin, and/or clopidogrel (not applicable for subjects taking anti-coagulation therapy or other approved anti-platelets therapy).

• 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