NCT06306573

CardioMEMS HF System Real-World Evidence Post-Approval Study

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 2,500 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Heart Failure NYHA Class II
• Heart Failure NYHA Class III

Interventions

Type	Name	Description
DEVICE	CardioMEMS 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.

Timeline

• Start date: 2022-12-15
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2024-03-12
• Last updated: 2025-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study