CardioMEMS HF System Real-World Evidence Post-Approval Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Heart Failure NYHA Class II; Heart Failure NYHA Class III
• Intervention / Treatment: Device: CardioMEMS HF System

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.

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30313
      • Abbott Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-Year Survival	Evaluate survival for the Primary and Full Cohorts at 3 years	3 years
HF Hospitalization Rate	Evaluate HF hospitalization rates in the Primary and Full Cohorts at 3 years	3 years
Pulmonary Artery (PA) Pressures Measured by the CardioMEMS PA Sensor	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.	3 years
Subject Compliance Rates with Weekly Pulmonary Artery (PA) Pressure Uploads	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.	3 years
Number of Subjects with Heart Failure (HF) Prescription Medication Fills	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.	3 years
Proportion of Subjects with Heart Failure (HF) Prescription Medication Fills	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.	3 years

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: CardioMEMS HF System
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CL1019613

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes