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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 Study

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Study Status Ongoing
Application Number /
Requirement Number
P190023 S002/ PAS002
Date Original Protocol Accepted 01/13/2023
Date Current Protocol Accepted  
Study Name Registry-Based Real-World Use Surveillance Study
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 valve for patients at high or greater surgical risk, undergoing TAVR with the Navitor valve and FlexNav delivery system (DS) 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 valve (23, 25, 27, or 29-mm sizes) using FlexNav Delivery System 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 valve with FlexNav Delivery System 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
Interim or Final Data Summary
Interim Results Safety Results
• A single Portico valve was implanted in 99.1% of the patients; 2 patients required a second Portico valve.
• The mean Procedure Time was 67.4 -/+ 34.6 minutes.
• Fourteen patients (6.5%) required concomitant procedures.
• Three (1.4%) valve-in-valve implantations.
• A total of 214 patients were discharged after the procedure.
• 30-days endpoints:
o All-cause mortality = 1.0%
o All stroke = 2.9%
o Life threatening or major bleeding = 1.0%
o New requirement for dialysis = 0.0%
o New permanent pacemaker implantation = 17.2%
o Peri-procedural myocardial infarction = 0.0%
o Reintervention – Aortic valve related = 1.0%
o Neurological (TIA / non-stroke) events = 0.5%
o Major vascular complications = 1.4%
o Minor vascular complications = 4.2%
Actual Number of Patients Enrolled 216
Actual Number of Sites Enrolled 17
Patient Follow-up Rate Of the 216 patients enrolled, 214 patients have discharge and 30-day follow-up data.
Two (2) patients died post procedure, but prior to discharge.
A total of 16 patients had no follow-up information available for the 30-day follow-up window as of the data cutoff.

Registry-Based Real-World Use Surveillance Study Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 03/18/2023 03/16/2023 On Time
1 year report 09/17/2023 09/15/2023 On Time
18 month report 07/31/2024    
2 year report 01/31/2025    
3 year report 01/31/2026    
4 year report 01/31/2027    
5 year report 01/31/2028    
6 year report 01/31/2029    
7 year report 01/31/2030    
final report 01/31/2031    

Contact Us

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

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