f Post-Approval Studies (PAS) Database
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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 Surv Navitor Titan


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General
Study Status Study Pending
Application Number /
Requirement Number		 P190023 S013/ PAS002
Date Original Protocol Accepted 09/15/2023
Date Current Protocol Accepted  
Study Name Registry-Based Real-World Use Surv Navitor Titan
Device Name Navitor Transcatheter Aortic Valve Implantation System, Navitor Transcatheter Aortic Heart Valve, FlexNav Delivery System, Navitor Loading System
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives The primary objective of this PAS is to confirm the long-term safety and effectiveness of the Navitor Titan valve for patients at high or greater surgical risk, undergoing TAVR with the Navitor Titan Transcatheter Aortic Valve System in a contemporary real-world setting. The study is an observational real-world surveillance study
Study Population All patients that have undergone attempted TAVR with Navitor Titan valve at a TVT Registry participating site, from the date of PMA approval (January 13, 2023) through January 13, 2025, who are at “high or greater risk” of mortality with open surgery.
Sample Size There is no minimum sample size. The PAS will include all consecutive patients who have a Navitor Titan valve implant attempt at institutions participating in the STS/ACC TVT Registry within the first 2 years following PAS start date.
Key Study Endpoints This surveillance will monitor the following: (1) device success (intra-procedure); (2) all-cause mortality, all stroke, life-threatening/major bleeding, new requirement for dialysis, new pacemaker implant, peri-procedural myocardial
infarction, and repeat procedure for valve-related dysfunction (surgical or interventional therapy) at 30 days and 12 months; (3) neurological (non-stroke), vascular complications, and quality of life (KCCQ) outcomes at 30 days and 12 months; and (4) all-cause mortality, all stroke, and repeat procedure for valve-related dysfunction (surgical or interventional therapy) annually at 2-5 year post implantation.
Follow-up Visits and Length of Follow-up 5 years post-implant


Registry-Based Real-World Use Surv Navitor Titan Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 07/31/2024    
1 year report 01/31/2025    
18 month report 07/31/2025    
2 year report 01/31/2026    
3 year report 01/31/2027    
4 year report 01/31/2028    
5 year report 01/31/2029    
6 year report 01/31/2030    
7 year report 01/31/2031    
final report 01/31/2032    


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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