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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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CMEMS RWE PAS


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General
Study Status Study Pending
Application Number /
Requirement Number
P100045 S056/ PAS001
Date Original Protocol Accepted 09/15/2022
Date Current Protocol Accepted  
Study Name CMEMS RWE PAS
Device Name CardioMEMs HF System
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives Real world evidence study to collect evidence for the continued safety and effectiveness of the CardioMEMS HF System for 3+ years after implant in NYHA Class II subjects (Primary Cohort) and NYHA Class II and III subjects (Full Cohort)
Study Population NYHA Class II subjects (Primary Cohort) implanted with the device and linked with claims data and NYHA Class II and III subjects (Full Cohort) implanted with the device and linked with claims data
Sample Size 1000 subjects for Primary Cohort and 2500 subjects for Full Cohort. The sample size was determined to ensure adequate enrollment of subgroups of interest and surpasses the sample size needed to evaluate the primary endpoints.
Key Study Endpoints The primary endpoint is survival for all-cause mortality in the Primary Cohort (NYHA Class II subjects) at 2 years. The analysis will evaluate survival for the Primary Cohort compared to a pre-specified performance goal of 71.7% survival at 2 years, established based on data from the literature. The secondary endpoint is survival for all-cause mortality in the Full Cohort (NYHA Class II and Class III subjects) at 2 years. The analysis will evaluate survival for the Full Cohort compared to a pre-specified performance goal of 69.6% survival at 2 years, established based on data from the literature (Appendix V. Performance Criteria). [Define the Main Effectiveness and Safety endpoints as well as the secondary endpoints.]
Follow-up Visits and Length of Follow-up Subjects will be followed for 3 years


CMEMS RWE PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 03/15/2023    
1 year report 09/15/2023    
18 month report 03/15/2024    
2 year report 09/15/2024    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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