CardioMEMS HF System Real-World Evidence Post-Approval Study

Launched by ABBOTT MEDICAL DEVICES · Mar 11, 2024

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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