Post-Approval Studies (PAS) Database

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

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: Freedom from Death with Vital Sweep: 98.6% Freedom from Valve Frame Facture: 100% Freedom from Device-related Endocarditis: 95.5% THV dysfunction: 12.2% (6/49): RVOT reintervention: 4.9% (3/61) Moderate or greater PR: 4.2% (2/48) Mean RVOT gradient >40 mmHg: 2.1% (1/48) Effectiveness Results: Mean RVOT gradient: Baseline: 27.4 mmHg; 5-year: 14.1 mmHg Peak RVOT gradient: Baseline: 47.5 mmHg; 5-year: 24.1 mmHg Paravalvular Regurgitation: 5-year: None – 95.8% (46/48); Trace – 2.1% (1/48); Mild – 2.1% (1/48) Total Pulmonary Regurgitation via TTE: Baseline: None: 5.9% (4/68); Trace: 1.5% (1/68); Mild: 10.3% (7/68); Moderate: 26.5% (18/68); Severe: 55.9% (38/68) Five-year: None: 72.9% (35/48); Trace: 6.3% (3/48); Mild: 16.7% (8/48); Moderate: 4.2% (2/48) Change in Total Pulmonary Regurgitation: Five-year: Improved: 89.6% (43/48); Stayed the same: 6.3% (3/48); Worsened: 2.1% (1/48)
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, 54 subjects (known status) of 68 total subjects implanted (in the 5-year window) results in a 54/68 (79.4%) rate

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	08/27/2025	On Time
final report	08/30/2026	10/14/2025	On Time

Contact Us

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background