CardioMEMS HF System Real-World Evidence Post-Approval Study

Enrolling by invitation

Conditions studied: Heart Failure NYHA Class II, Heart Failure NYHA Class III

In brief

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.

Key facts

Study ID

NCT06306573

Run by

Abbott Medical Devices

People needed

2500

Starts

2022-12-15

Expected to finish

2029-12-31

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Abbott Medical — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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