Heart Failure Clinical Trial
CardioMEMS HF System Post Approval Study
Summary
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.
Full Description
The primary objective of this study is to demonstrate the safety and to report clinical performance of the CardioMEMSâ„¢ HF System in real world setting.
Prospective, non-randomized, open-label, multi-center, post-market study designed to characterize the use of the CardioMEMSâ„¢ HF System in a real-world setting in the US; N=1200. It is the condition of approval study.
Eligibility Criteria
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
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There is 1 Location for this study
Morgantown West Virginia, 26505, United States
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