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Enrolling by invitation NCT06306573

CardioMEMS HF System Real-World Evidence Post-Approval Study

— Observational Heart Failure NYHA Class II Heart Failure NYHA Class III

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CardioMEMS HF System.
Who it may be relevant to
Registry conditions: Heart Failure NYHA Class II, Heart Failure NYHA Class III. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Two-Year Survival in NYHA Class II subjects without a history of severe renal disease [Time frame: 2 years]
Secondary outcome measures (1)
  • Two-Year Survival in NYHA Class II and III subjects without a history of severe renal disease [Time frame: 2 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Abbott Medical — Atlanta

Identifiers

NCT: NCT06306573 · CL1019613

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗