CardioMEMS HF System Real-World Evidence Post-Approval Study

• Conditions: Heart Failure NYHA Class II; Heart Failure NYHA Class III
• Interventions: Device: CardioMEMS HF System

• Registration Number: NCT06306573
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study Start: 2022-12-15
• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2024-03-11
• Study First Posted: 2024-03-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-03
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 2500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary Cohort	CardioMEMS HF System	The Primary Cohort will include NYHA Class II heart failure subjects receiving a CardioMEMS PA Sensor implant in the commercial setting.
Full Cohort	CardioMEMS HF System	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.

Primary Outcome Measures

Name	Time	Method
Two-Year Survival in the Primary Cohort (NYHA Class II subjects)	2 years	Evaluate survival for the Primary Cohort compared to a pre-specified performance goal of 71.7% survival at 2 years.

Secondary Outcome Measures

Name	Time	Method
Two-Year Survival in the Full Cohort (NYHA Class II and Class III subjects)	2 years	Evaluate survival for the Full Cohort compared to a pre-specified performance goal of 69.6% survival at 2 years.

Trial Locations

Locations (1)

Abbott Medical; 🇺🇸 Atlanta, Georgia, United States