Studies a heart pressure sensor in people with heart failure
Observes how the CardioMEMS sensor device is used in adults with heart failure.
Plain-language title generated from the registry record
Registry title: CardioMEMS HF System Real-World Evidence Post-Approval Study
Key facts
- Where
- Atlanta, United StatesSee the site
Where in United States
- Abbott MedicalAtlanta, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Abbott Medical Devices
- Trial code
- NCT06306573
- Record updated
- 9 July 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Subject received heart transplant or durable mechanical circulatory support device implant (i.e., left/right/bi-ventricular assist device) prior to CardioMEMS implant.