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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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Alterra New Enrollment Study


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General
Study Status Study Pending
Application Number /
Requirement Number
P200015 S011/ PAS002
Date Original Protocol Accepted 12/16/2021
Date Current Protocol Accepted 06/23/2022
Study Name Alterra New Enrollment Study
Device Name Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is a prospective, multi-center, single-arm new enrollment study. The objective of the study is to characterize the real-world performance of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Edwards Alterra Adaptive Prestent through 10 years post implant.
Study Population Patients with severe pulmonary regurgitation who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for pulmonary valve replacement.
Sample Size 150
Key Study Endpoints Acute device success, transcatheter heart valve dysfunction, echocardiographic assessments, New York Heart Association (NYHA) functional class, and adverse events device (including device frame fracture).
Follow-up Visits and Length of Follow-up 10 years


Alterra New Enrollment Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 12/16/2022    
2 year report 12/16/2023    
3 year report 12/15/2024    
4 year report 12/15/2025    


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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