NCT06306573Enrolling by invitation
CardioMEMS HF System Real-World Evidence Post-Approval Study
CardioMEMS™ HF System Real-World Evidence Post-Approval Study
Source: ClinicalTrials.gov · Last updated 9 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 2500 (estimated)
- First submitted
- 14 Nov 2023
- Start date
- Dec 2022
- Primary completion date
- Dec 2028
- Lead sponsor
- Abbott Medical Devices
- Diseases
- Heart failure
- NCT number
- NCT06306573
What you commit to
- Study type: Observational
- Planned participants: 2500
- From Dec 2022 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject received heart transplant or durable mechanical circulatory support device implant (i.e., left/right/bi-ventricular assist device) prior to CardioMEMS implant
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Abbott Medical Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.