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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 Ongoing
Application Number /
Requirement Number		 P100045 S056/ PAS001
Date Original Protocol Accepted 09/15/2022
Date Current Protocol Accepted 06/01/2026
Study Name CMEMS RWE PAS
Device Name CardioMEMs HF System
Clinical Trial Number(s) NCT03387813  
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives The CMEMS RWE PAS is aimed to collect evidence for continued safety and effectiveness of the CardioMEMS HF System for 3+ years after implant. It is a prospective, observational, single-arm, real-world evidence (RWE) study to be conducted in the US. Subjects will be identified in Abbott’s Merlin.net remote monitoring database. Merlin.net will be linked to Medicare fee-for-service (FFS) claims data at the individual subject level through probabilistic linking methods (based on subject date of birth, sex, and date of implant) to longitudinally track outcomes. The analysis will compare survival in a subset of subjects from the Primary Cohort and Full Cohort to a pre-specified performance goal of 71.7% survival at 2 years, established based on data from the literature.
Study Population NYHA Class II and NYHA Class II and III subjects
Sample Size The enrollment target is 1000 subjects for the Primary Endpoint Population while 2500 subjects in the Secondary Endpoint Population.
Key Study Endpoints The primary endpoint for this study is survival from all-cause mortality in the Primary Endpoint Population at 2 years. The secondary endpoint for this study is survival from all-cause mortality in the Secondary Endpoint Population at 2 years.
Follow-up Visits and Length of Follow-up The duration of enrollment for the Primary Cohort is expected to be approximately four years from enrollment of the first subject to the last subject, with an additional three years of follow-up. Study completion will occur once data sources for the complete 3-year follow-up of the last subject become available.
Interim or Final Data Summary
Actual Number of Patients Enrolled 19851
Actual Number of Sites Enrolled 1041


CMEMS RWE PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 03/15/2023 03/15/2023 On Time
1 year report 09/15/2023 09/14/2023 On Time
18 month report 03/15/2024 03/15/2024 On Time
2 year report 09/15/2024 09/16/2024 Overdue/Received
30 month report 03/15/2025 03/13/2025 On Time
3 year report 09/15/2025 09/15/2025 On Time
42 month report 03/15/2026 03/13/2026 On Time
4 year report 09/15/2026    
final report 08/15/2029    


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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