CardioMEMS HF System Post Approval Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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CardioMEMS HF System Post Approval Study

Conditions
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Heart Failure, Left-Sided Heart Failure, Congestive Heart Failure

Intervention / Treatment
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* Device: CardioMEMS HF System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CardioMEMS HF System Group<br>Patients implanted with a CardioMEMS HF System. | Device: CardioMEMS HF System<br>* Pulmonary artery pressure sensor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| freedom from device/system related complication |  | two year | 
| freedom from pressure sensor failure |  | two year | 
| heart failure hospitalization rate |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Artery Pressure Monitoring, Implantable Hemodynamic Monitor