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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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Registry-Based Real-World Use Surveillance


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General
Study Status Study Pending
Application Number /
Requirement Number		 P220003 / PAS002
Date Original Protocol Accepted 09/14/2022
Date Current Protocol Accepted  
Study Name Registry-Based Real-World Use Surveillance
Device Name PASCAL Precision Transcatheter Valve Repair System
General Study Protocol Parameters
Study Design Active Surveillance
Data Source External Registry
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Comprehensive/linked/registry-based surveillance. The objective of the surveillance is to assess the real-world performance of the PASCAL Precision system.
Study Population The surveillance will involve all consecutive patients treated within the first 2 years that are entered into the TVT Registry (enrollment period)
Sample Size All consecutive patients treated within the first 2 years in the commercial setting that are entered into the TVT Registry.
Key Study Endpoints The clinical data through one (1) year are collected through the TVT Registry. The follow-up data (including all-cause mortality, stroke, repeat procedure for mitral valve-related dysfunction, and hospitalization) from year 2 through year 5 post procedure are obtained through linking the TVT data with the Centers for Medicare and Medicaid Services (CMS) claims database.
Follow-up Visits and Length of Follow-up 5 years


Registry-Based Real-World Use Surveillance Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 09/14/2023   Overdue
2 year report 09/13/2024    
3 year report 09/13/2025    
4 year report 09/13/2026    
5 year report 09/13/2027    


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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