CardioMEMS HF System Real-World Evidence Post-Approval Study

NCT ID: NCT06306573

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 2500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2028-12-31

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.

Conditions

Heart Failure NYHA Class II; Heart Failure NYHA Class III

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Primary Cohort

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

CardioMEMS HF System

Intervention Type: DEVICE

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.

Full Cohort

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.

CardioMEMS HF System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Abbott Medical

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

CL1019613

Identifier Type: -

Identifier Source: org_study_id