CardioMEMS HF System Post Approval Study

CardioMEMS HF System Post Approval Study

The purpose of the CardioMEMS HF System Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial setting.

The primary objective of this study is to demonstrate the safety and to report clinical performance of the CardioMEMS™ HF System in real world setting.

Prospective, non-randomized, open-label, multi-center, post-market study designed to characterize the use of the CardioMEMS™ HF System in a real-world setting in the US; N=1200. It is the condition of 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