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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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Continued F/U of the IDE Portico NG Study


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General
Study Status Ongoing
Application Number /
Requirement Number		 P190023 S002/ PAS001
Date Original Protocol Accepted 01/13/2023
Date Current Protocol Accepted  
Study Name Continued F/U of the IDE Portico NG 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 Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives The study objective is to characterize the acute safety and effectiveness of the Navitor Transcatheter Aortic Heart Valve through 5 years post procedure in patients with symptomatic, severe aortic stenosis who are considered high or greater surgical risk. The study is a prospective, multi-center, single-arm study.
Study Population Patients with symptomatic, severe aortic stenosis who are considered high or extreme surgical risk.
Sample Size All living subjects enrolled under the IDE Portico NG Approval study, including all analysis, roll-in, and continued access cohorts
Key Study Endpoints The safety and effectiveness endpoints include, but are not limited to: all-cause mortality, all-cause and disabling stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, major vascular complications, paravalvular aortic regurgitation, myocardial infarction, re-operation for valve-related dysfunction, rehospitalization for valve-related symptoms or worsening congestive heart failure, new permanent pacemaker implantation, new-onset atrial fibrillation, functional status as evaluated by New York Heart Association (NYHA), health status as evaluated by Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) through 1 year, and hemodynamic performance metrics by echocardiography.
Follow-up Visits and Length of Follow-up 5 years


Continued F/U of the IDE Portico NG Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 01/13/2024 01/12/2024 On Time
2 year report 01/12/2025    
3 year report 01/12/2026    
4 year report 01/12/2027    
5 year report 01/12/2028    


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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