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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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Harmony TPV New Enrollment Study


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General
Study Status Progress Adequate
Application Number /
Requirement Number
P200046 / PAS002
Date Original Protocol Accepted 03/26/2021
Date Current Protocol Accepted 04/08/2022
Study Name Harmony TPV New Enrollment Study
Device Name Harmony™ TPV System
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 N/A - Adverse Events: There has been no site reported adverse events, device deficiencies, surgical or catheter reinterventions reported for the study as of the data cutoff date.


Actual Number of Patients Enrolled 5 subjects enrolled, 2 implanted

Actual Number of Sites Enrolled 5
Patient Follow-up Rate N/A – first patient was implanted on October 27, 2021; therefore, no patients have reached 6-month follow-up yet.

Final Effect Findings N/A – 2 patients have been implanted and 0 have reached 6-month follow-up.



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    
3 year report 03/25/2024    
4 year report 03/25/2025    
5 year report 03/25/2026    
6 year report 03/25/2027    
7 year report 03/24/2028    
8 year report 03/24/2029    
9 year report 03/24/2030    
10 year report 03/24/2031    


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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