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The purpose of this post-approval study (PAS) is to evaluate the long-term safety and effectiveness of the CardioMEMSâ„¢ HF System using real-world evidence (RWE) methods.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Cohort | The Primary Cohort will include NYHA Class II heart failure subjects receiving a CardioMEMS PA Sensor implant in the commercial setting. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Two-Year Survival in NYHA Class II subjects without a history of severe renal disease | 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Two-Year Survival in NYHA Class II and III subjects without a history of severe renal disease | 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 | 2 years |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbott Medical | Atlanta | Georgia | 30313 | United States |
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| 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 |