Heart Failure NYHA Class III Clinical Trial
Official title:
CardioMEMS™ HF System Real-World Evidence Post-Approval Study
Verified date | March 2024 |
Source | Abbott Medical Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Abbott Medical | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices |
United States,
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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