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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 of the Portico


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General
Study Status Ongoing
Application Number /
Requirement Number		 P190023 / PAS002
Date Original Protocol Accepted 11/12/2021
Date Current Protocol Accepted 11/12/2021
Study Name Registry-Based Real World use Surv of the Portico
Device Name Portico Transcatheter Aortic Valve Implantation System
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives The primary objective of this Portico PAS is to confirm the long-term safety and effectiveness of the Portico valve for
patients undergoing TAVR with the Portico valve and FlexNav delivery system (DS) in a contemporary real-world setting.
The study will be a prospective, single-arm, multi-center, observational real-world surveillance study.
Study Population All patients that have undergone attempted TAVR with Portico valve (23, 25, 27, or 29-mm sizes) using FlexNav
Delivery System at a TVT Registry participating site, from the date of PMA approval (September 17, 2021) through
September 24, 2023.
Sample Size There is no minimum sample size. The PAS will include all consecutive patients who have a Portico 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 Successfully implanted patients will be followed through one (1) year via STS/ACC TVT Registry and through five (5) years
via CMS claims data linkage. Patients with attempted but unsuccessful implants with the Portico valve will be followed
through 30 days post-procedure.


Registry-Based Real World use Surv of the Portico Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 03/18/2022 03/16/2022 On Time
1 year report 09/17/2022 10/24/2022 Overdue/Received
18 month report 03/18/2023    
2 year report 09/17/2023    
3 year report 09/16/2024    
4 year report 09/16/2025    
5 year report 09/16/2026    
6 year report 09/16/2027    
7 year report 09/15/2028    
final report 09/15/2029    


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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