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Enrolling by Invitation

NCT Number: NCT06306573

CardioMEMS HF System Real-World Evidence Post-Approval Study

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.

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Key information

Conditions

Heart Failure NYHA Class II Heart Failure NYHA Class III

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Abbott Medical

Atlanta, Georgia, 30313, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Two-Year Survival in NYHA Class II subjects without a history of severe renal disease

    Time frame: 2 years

    Compare survival in a subset of subjects from the Primary Cohort without a history of severe renal disease to a pre-specified performance goal of 71.7% survival at 2 years

Secondary outcomes

  1. Two-Year Survival in NYHA Class II and III subjects without a history of severe renal disease

    Time frame: 2 years

    Compare survival in a subset of subjects from the Full Cohort without a history of severe renal disease to a pre-specified performance goal of 68.6% survival at 2 years

Other outcomes

  1. 3-Year Survival

    Time frame: 3 years

    Evaluate survival for the Primary and Full Cohorts at 3 years

  2. HF Hospitalization Rate

    Time frame: 3 years

    Evaluate HF hospitalization rates in the Primary and Full Cohorts at 3 years

  3. Pulmonary Artery (PA) Pressures Measured by the CardioMEMS PA Sensor

    Time frame: 3 years

    Systolic, diastolic, and mean PA pressures submitted to Merlin.net from the CardioMEMS PA sensor will be evaluated at fixed timepoints every 6 months (e.g., baseline, 6 months, 12 months, etc) in the Primary and Full Cohorts.

  4. Subject Compliance Rates with Weekly Pulmonary Artery (PA) Pressure Uploads

    Time frame: 3 years

    Subject compliance rates with weekly PA pressure uploads will be evaluated in the Primary and Full Cohorts from 0 to 3 years. The compliance rate will be calculated for each subject as the number weeks with at least 1 PA pressure upload to Merlin.net divided by the total number of weeks of follow-up.

  5. Number of Subjects with Heart Failure (HF) Prescription Medication Fills

    Time frame: 3 years

    The number of patients with prescription claims for HF medications of interest will be reported from 0 - 3 years in the Full Cohort. Data will be reported as the number of subjects who have at least 1 prescription filled for each of the following drug classes during each 6-month interval of follow-up: angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, angiotensin receptor-neprilysin inhibitor, beta blocker, mineralocorticoid receptor antagonist, diuretics, hydralazine, nitrates, and sodium-glucose cotransport-2 inhibitor.

  6. Proportion of Subjects with Heart Failure (HF) Prescription Medication Fills

    Time frame: 3 years

    The proportion of patients with prescription claims for HF medications of interest will be reported from 0 - 3 years in the Full Cohort. Data will be reported as the proportion of subjects who have at least 1 prescription filled for each of the following drug classes during each 6-month interval of follow-up: angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, angiotensin receptor-neprilysin inhibitor, beta blocker, mineralocorticoid receptor antagonist, diuretics, hydralazine, nitrates, and sodium-glucose cotransport-2 inhibitor.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2029
First posted
Mar 12, 2024
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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