Post-Approval Studies (PAS) Database

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

General
Study Status	Ongoing
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
Clinical Trial Number(s)	NCT04011722
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	07/25/2024	On Time
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

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background