CardioMEMS HF System Real-World Evidence Post-Approval Study (NCT06306573) | Clinical Trial Compass
By InvitationNot Applicable
CardioMEMS HF System Real-World Evidence Post-Approval Study
United States2,500 participantsStarted 2022-12-15
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Two-Year Survival in the Primary Cohort (NYHA Class II subjects)