CardioMEMS HF System Real-World Evidence Post-Approval Study

N/AEnrolling By InvitationNCT06306573

Abbott Medical Devices2,500 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

2,500

Conditions

Heart Failure NYHA Class II Heart Failure NYHA Class III

Interventions

CardioMEMS HF SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Abbott Medical

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

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

Evaluate survival for the Full Cohort compared to a pre-specified performance goal of 69.6% survival at 2 years.

Time frame: 2 years

Data from ClinicalTrials.gov

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