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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06306573
Other study ID # CL1019613
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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