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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Harmony TPV New Enrollment Study

General
Study Status	Ongoing
Application Number / Requirement Number	P200046 / PAS002
Date Original Protocol Accepted	03/26/2021
Date Current Protocol Accepted	03/22/2024
Study Name	Harmony TPV New Enrollment Study
Device Name	Harmony™ TPV System
Clinical Trial Number(s)	NCT02979587
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	A prospective, single-arm, multi-center study. The objective of the study is to characterize the real-world performance of the Harmony TPV through 10 years post implant.
Study Population	Patients with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as determined by echocardiography and/or pulmonary regurgitant fraction greater than or equal to 30% as determined by cardiac magnetic resonance imaging) who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for surgical pulmonary valve replacement.
Sample Size	150
Key Study Endpoints	Proportion of patients without valve intervention and with acceptable hemodynamic function at 6 months, procedure success at 30 days, as well as freedom from all-cause mortality, freedom from reoperation, freedom from catheter reintervention, freedom from TPV dysfunction, and serious procedure- and device-related adverse events at 6 months and annually through 10 years.
Follow-up Visits and Length of Follow-up	10 years
Interim or Final Data Summary
Interim Results	Safety Results Number of Subjects with CEC Adjudicated Adverse Events: Fever (2); Heart block, 3rd degree: (1); Hemorrhage: major (1); Ventricular premature beats (1); Ventricular tachycardia (1) Effectiveness Results There have been no surgical or catheter reinterventions reported. There has been 1 event of Type I Stent Fracture without loss of stent integrity.
Actual Number of Patients Enrolled	64 (implanted)
Actual Number of Sites Enrolled	18
Patient Follow-up Rate	100% at discharge

Harmony TPV New Enrollment Study Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
6 month report	09/26/2021	10/12/2021	Overdue/Received
1 year report	03/26/2022	03/28/2022	Overdue/Received
2 year report	03/26/2023	03/24/2023	On Time
3 year report	03/26/2024	03/21/2024	On Time
4 year report	03/26/2025
5 year report	03/26/2026
6 year report	03/26/2027
7 year report	03/26/2028
8 year report	03/26/2029
9 year report	03/26/2030
10 year report	03/26/2031

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