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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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Cont f/u of the PORTICO IDE cohorts


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General
Study Status Ongoing
Application Number /
Requirement Number		 P190023 / PAS001
Date Original Protocol Accepted 09/17/2021
Date Current Protocol Accepted  
Study Name Cont f/u of the PORTICO IDE cohorts
Device Name Portico Transcatheter Aortic Valve Implantation System
Clinical Trial Number(s) NCT02000115 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent 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 Portico 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, randomized controlled trial (RCT) that also included non-randomized arms: Roll-in Registry, FlexNav Study, Extreme Risk Registry and Valve-in-Valve (ViV) Registry.
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 approval studies, including all analysis, registry, 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 Kansas City Cardiomyopathy Questionnaire (KCCQ), and
· hemodynamic performance metrics by echocardiography.
Follow-up Visits and Length of Follow-up 5 years


Cont f/u of the PORTICO IDE cohorts Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 09/17/2022 09/14/2022 On Time
2 year report 09/17/2023 09/15/2023 On Time
3 year report 09/16/2024 09/12/2024 On Time
final report 09/16/2025 09/10/2025 On Time


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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