CardioMEMS HF System Real-World Evidence Post-Approval Study

NCT06306573 | Enrolling By Invitation FDA Device

• 1 other identifier: CL1019613
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure NYHA Class II; Heart Failure NYHA Class III

Keywords

CardioMEMS HF System

Outcome Measures

Primary Outcomes (1)

• Two-Year Survival in the Primary Cohort (NYHA Class II subjects)

  Evaluate survival for the Primary Cohort compared to a pre-specified performance goal of 71.7% survival at 2 years.

  2 years

Secondary Outcomes (1)

• Two-Year Survival in the Full Cohort (NYHA Class II and Class III subjects)

  2 years

Other Outcomes (6)

• 3-Year Survival

  3 years

• HF Hospitalization Rate

  3 years

• Pulmonary Artery (PA) Pressures Measured by the CardioMEMS PA Sensor

  3 years

Study Arms (2)

Primary Cohort

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

Device: CardioMEMS HF System

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.

Device: CardioMEMS HF System

Interventions

CardioMEMS HF System 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; Primary Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The intended population for this RWE PAS includes Medicare FFS beneficiaries with symptomatic NYHA Class II and III heart failure implanted with a CardioMEMS PA Sensor in the commercial setting.

You may qualify if:

• 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

You may not qualify if:

• Subject received heart transplant or durable mechanical circulatory support device implant (i.e., left/right/bi-ventricular assist device) prior to CardioMEMS implant

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Abbott Medical

Atlanta, Georgia, 30313, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: March 12, 2024
• Study Start: December 15, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)