CardioMEMS HF System Real-World Evidence Post-Approval Study

Abbott

Status: Invitation-only

Conditions: Heart Failure NYHA Class II; Heart Failure NYHA Class III

Treatments: Device: CardioMEMS HF System

Study type: Observational

Funder types: Industry

Identifiers

NCT06306573

CL1019613

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,500 participants in 2 patient groups

Primary Cohort

Description:

The Primary Cohort will include NYHA Class II heart failure subjects receiving a CardioMEMS PA Sensor implant in the commercial setting.

Treatment:

Device: CardioMEMS HF System

Full Cohort

Description:

The Full Cohort will include both NYHA Class II and Class III heart failure subjects receiving a CardioMEMS PA Sensor implant in the commercial setting.

Treatment:

Device: CardioMEMS HF System