CardioMEMS HF System Real-World Evidence Post-Approval Study

Heart Failure NYHA Class III Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06306573
• Other study ID #: CL1019613
• Status: Enrolling by invitation
• Start date: December 15, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: March 2024
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2500
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure NYHA Class II
• Heart Failure NYHA Class III

Intervention

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.

Locations

Country	Name	City	State
United States	Abbott Medical	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	3-Year Survival	Evaluate survival for the Primary and Full Cohorts at 3 years	3 years
Other	HF Hospitalization Rate	Evaluate HF hospitalization rates in the Primary and Full Cohorts at 3 years	3 years
Other	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
Other	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
Other	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
Other	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
Primary	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	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