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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 Alterra IDE Cohort


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General
Study Status Ongoing
Application Number /
Requirement Number		 P200015 S011/ PAS001
Date Original Protocol Accepted 12/16/2021
Date Current Protocol Accepted  
Study Name Cont f/u of the Alterra IDE Cohort
Device Name Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent
Clinical Trial Number(s) NCT03130777  
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No 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 Continued follow-up of all living subjects enrolled under IDE G170053, including the Continued Access Protocol investigation subjects. The objective of this study is to characterize the clinical outcomes of these subjects annually through 10 years post-procedure.
Study Population All living subjects enrolled under IDE G170053, including the Continued Access Protocol subjects.
Sample Size 119
Key Study Endpoints Right ventricular outflow tract/pulmonary valve reintervention, transcatheter heart valve hemodynamic function, and adverse events (including device frame fracture).
Follow-up Visits and Length of Follow-up 10 years
Interim or Final Data Summary
Interim Results Safety Results:
Freedom from RVOT/PV reintervention (3-years): 97.2%
Freedom from death (with vital status, 3-years): 96.3%
Alterra Pre-stent fracture (3-year Kaplan-Meier rate): 35.2%
Sapien 3 valve frame fracture (3-year Kaplan-Meier rate): 0.0%

Effectiveness Results:
Mean RVOT gradient
baseline – 9.7 mmHg; 1 year – 9.8 mmHg; 3 years – 9.6 mmHg
Total pulmonic regurgitation
3 years: None – 56.2% (41/73); Trace – 15.1% (11/73); Mild – 20.5% (15/73); Moderate – 6.8% (5/73); Severe – 1.4% (1/73)
Paravalvular regurgitation
3 years: None – 97.8% (71/73); Trace – 1.4% (1/73); Mild – 1.4% (1/73); Moderate - 0.0% (0/73); Severe - 0.0% (0/73)
Site Reported Adverse Events of Interest at 3 years
Endocarditis: 1.1%
Actual Number of Patients Enrolled Enrolled: 121; Valve implanted: 118
Actual Number of Sites Enrolled 14
Patient Follow-up Rate At 3 years, 98 subjects (94 alive, 4 dead) out of 118 subjects with the study devices implanted had known status (83.1%).


Cont f/u of the Alterra IDE Cohort Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 12/16/2022 12/15/2022 On Time
2 year report 01/29/2024 01/29/2024 On Time
3 year report 01/29/2025 01/27/2025 On Time
4 year report 01/29/2026    
5 year report 01/29/2027    
6 year report 01/29/2028    
7 year report 01/29/2029    
8 year report 01/29/2030    
9 year report 01/29/2031    


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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