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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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Continued Follow-up of the Harmony TPV IDE Cohort


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General
Study Status Ongoing
Application Number /
Requirement Number		 P200046 / PAS001
Date Original Protocol Accepted 03/26/2021
Date Current Protocol Accepted 11/03/2023
Study Name Continued Follow-up of the Harmony TPV IDE Cohort
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 Continued follow-up of all patients enrolled under IDE G120175, including the Continued Access Protocol investigation patients. The objective of the study is to characterize the clinical outcomes annually, unless otherwise specified, through 10 years post implant.
Study Population All patients enrolled under IDE G120175, including the Continued Access Protocol investigation patients.
Sample Size 82
Key Study Endpoints Device success, freedom from TPV dysfunction, freedom from all-cause mortality, serious device-related adverse events, quality of life score (SF-36; 6 months, 2 years, 5 years and 10 years), and reoperation.
Follow-up Visits and Length of Follow-up 10 years
Interim or Final Data Summary
Interim Results Safety Results
Known device- or procedure-related mortality at 3 years: 0 Freedom from stent fracture at 3 years: 99.0%

Effectiveness results
Device success at 3 years: 77.2%
Freedom from TPV dysfunction at 3 years: 85.5%
Freedom from reoperation at 3 years: 95.1%
Freedom from catheter reintervention at 3 years: 92.7%
Actual Number of Patients Enrolled 108 (catheterized_
Actual Number of Sites Enrolled 10 (global)
Patient Follow-up Rate 86.8% at 3 years


Continued Follow-up of the Harmony TPV IDE Cohort Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
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
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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