CardioMEMS HF System Real-World Evidence Post-Approval Study

CardioMEMS™ HF System Real-World Evidence Post-Approval Study

The purpose of this post-approval study (PAS) is to evaluate the long-term safety and effectiveness of the CardioMEMS™ HF System using real-world evidence (RWE) methods.

Subjects will be identified in Abbott's Merlin.net remote monitoring database. Merlin.net data will be linked to Medicare fee-for-service (FFS) claims data to longitudinally track outcomes. Each subject will be followed for a minimum of 36 months.

Inclusion Criteria:

• Subject implanted with a CardioMEMS PA Sensor and enrolled in Merlin.net
• Subject resides in the United States as documented in Merlin.net
• NYHA Class II or Class III as documented in Merlin.net at the time of CardioMEMS implant (only NYHA Class II subjects contribute to the Primary Cohort)
• Subject identified in Merlin.net data can be linked to Medicare FFS claims
• Subject is enrolled in Medicare Part A and B, and not enrolled in Medicare Part C, at implant and for 12 months prior to implant, to establish qualification for CardioMEMS
• Subject ≥18 years of age at time of CardioMEMS implant

Exclusion Criteria:

• Subject received heart transplant or durable mechanical circulatory support device implant (i.e., left/right/bi-ventricular assist device) prior to CardioMEMS implant