Abbott Medical Devices
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 ti…
The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data to monitor and manage HF subjects. The CardioMEMS HF System measures PA pressure which clinicians use to initiate or modify HF treatment.
Arctuva estimate
Actual pay is set by the research site.
Verify or correct the compensation shown for this listing.