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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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SAPIEN 3 Pulmonic Long Term F/u Study


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General
Study Status Ongoing
Application Number /
Requirement Number		 P200015 / PAS001
Date Original Protocol Accepted 08/06/2020
Date Current Protocol Accepted  
Study Name SAPIEN 3 Pulmonic Long Term F/u Study
Device Name Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System
Clinical Trial Number(s) NCT02744677 
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, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives Continued follow-up of all living subjects enrolled under IDE G150220, including the Continued Access Protocol subjects. The objective of this study is to characterize the clinical outcomes of these subjects annually through 5 years post-procedure.
Study Population All living subjects enrolled under IDE G150220, including the Continued Access Protocol subjects.
Sample Size All living subjects.
Key Study Endpoints Mortality, transcatheter heart valve (THV) dysfunction, THV hemodynamic function, THV frame fracture, and device-related endocarditis.
Follow-up Visits and Length of Follow-up 5 years
Interim or Final Data Summary
Interim Results Safety Results
At 5 years:
THV dysfunction: 15.6% (5/32)
RVOT reintervention: 6.3% (3/48)
Moderate or greater PR: 3.3% (1/30)
Mean RVOT gradient > 40 mmHg: 3.3% (1/30)
Freedom from Death: 98.5%
Freedom from Valve Frame Facture: 100%
Freedom from Device-related Endocarditis: 95.1%

Effectiveness results:
Mean RVOT gradient: Baseline: 27.4 mmHg; 1-year: 13.2 mmHg; 5-year: 17.4 mmHg
Peak RVOT gradient: Baseline: 47.5 mmHg; 1-year: 23.3 mmHg; 5-year: 29.4 mmHg
Paravalvular Regurgitation:
5-year: None – 93.3% (28/30); Trace – 3.3% (1/30); Mild – 3.3% (1/30)
Total pulmonary regurgitation:
5-year: Improved – 83.3% (25/30); Worsened – 3.3% (1/30); Stayed the same – 10.0% (3/30)
Actual Number of Patients Enrolled 72 total subjects in main cohort and 14 in CAP were enrolled. 56 in main and 13 in CAP were implanted
Actual Number of Sites Enrolled 11
Patient Follow-up Rate At 5 years, 44 subjects (with known status) of 58 total subjects that have reached 5-year follow up results in a 44/58 (76%) 5-year follow-up rate at this time.


SAPIEN 3 Pulmonic Long Term F/u Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 08/31/2021 08/30/2021 On Time
2 year report 08/31/2022 08/30/2022 On Time
3 year report 08/31/2023 08/31/2023 On Time
4 year report 08/30/2024 08/30/2024 On Time
5 year report 08/30/2025    


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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