Clinical Trials in the USA / NCT06306573
Enrolling by invitation
Observational
CardioMEMS HF System Real-World Evidence Post-Approval Study
NCT06306573 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Heart Failure NYHA Class IIHeart Failure NYHA Class III
Investigational drug(s) / intervention(s)
CardioMEMS HF System
CardioMEMS HF System: The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data to monitor and manage HF subjects. The CardioMEMS HF System measures PA pressure which clinicians use to initiate or modify HF treatment.
Study 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.
Eligibility
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
Primary outcome measure(s)
- Two-Year Survival in NYHA Class II subjects without a history of severe renal disease — 2 years
Compare survival in a subset of subjects from the Primary Cohort without a history of severe renal disease to a pre-specified performance goal of 71.7% survival at 2 years
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Abbott Medical | Atlanta | Georgia |
More Abbott Medical Devices trials in the USA
TRILUMINATE Pivotal Trial
Active, not recruiting
SyncAV Post-Market Trial
Active, not recruiting
LIFE-BTK PK Sub-study
Active, not recruiting
LIFE-BTK Randomized Controlled Trial
Active, not recruiting
Other trials for the same condition
An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure
Active, not recruiting
PROACTIVE-HF IDE Trial Heart Failure NYHA Class III
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06306573 on ClinicalTrials.gov ↗ ← All trials in the USA