NCT06306573
CardioMEMS HF System Real-World Evidence Post-Approval Study
Enrolling by Invitation
Not specifiedAges 18+ObservationalAbbott Medical Devices
~2,500 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:CardioMEMS HF System
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Two-Year Survival in NYHA Class II subjects without a history of severe renal disease
Measured over 2 years
Conditions
Where it's being run
1 sites across 1 statesGeorgia1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
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
What this trial measures
- Two-Year Survival in NYHA Class II subjects without a history of severe renal disease2 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