CardioMEMS™ HF System Real-World Evidence Post-Approval Study

Abbott Medical Devices1 site in 1 country2,500 target enrollmentDecember 15, 2022

ConditionsHeart Failure NYHA Class II Heart Failure NYHA Class III

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure NYHA Class II
Sponsor: Abbott Medical Devices
Enrollment: 2500
Locations: 1
Primary Endpoint: Two-Year Survival in the Primary Cohort (NYHA Class II subjects)
Status: Enrolling By Invitation
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 15, 2022

End Date

December 31, 2028

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

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