CardioMEMS HF System Coverage With Evidence Development Study

The CardioMEMS CED Study will assess 2-year HF hospitalization rates and survival for all-cause mortality in heart failure subjects managed with the CardioMEMS HF system, as compared to a contemporaneous control of HF subjects managed without PA pressure-guidance.

Inclusion criteria

• Subject implanted with a CardioMEMS pressure sensor (treatment arm only)
• Subject >=18 years of age at time of implant
• Subject has a history of acute decompensated HF or HF-related congestion defined by at least one of the following qualifying event types: HF hospitalization, elevated BNP/NT-proBNP

Exclusion criteria

• Subject has history of heart transplant or durable mechanical circulatory device
• Subject hospitalized with cardiogenic shock or sepsis
• Subject received prior PA pressure sensor implant (control arm only)