Heart Failure NYHA Class II, Heart Failure NYHA Class III
Conditions
Keywords
CardioMEMS HF System
Brief 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.
Detailed description
Subjects will be identified in Abbott's Merlin.net remote monitoring database. Merlin.net data will be linked to Medicare fee-for-service (FFS) claims data to longitudinally track outcomes. Each subject will be followed for a minimum of 36 months.
Interventions
DEVICECardioMEMS 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.
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Two-Year Survival in NYHA Class II and III subjects without a history of severe renal disease | 2 years | Compare survival in a subset of subjects from the Full Cohort without a history of severe renal disease to a pre-specified performance goal of 68.6% survival at 2 years |
Countries
United States
Outcome results
None listed