Overview
The purpose of the CardioMEMS CED Study is to determine if pulmonary artery (PA) pressure-guided heart failure management using the CardioMEMS™ HF System improves long-term health outcomes in heart failure (HF) patients in the real-world setting.
Description
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.
Eligibility
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)