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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 Progress Adequate
Application Number /
Requirement Number
P200046 / PAS001
Date Original Protocol Accepted 03/26/2021
Date Current Protocol Accepted 04/08/2022
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 One-hundred and six subjects were successfully implanted with the device in the Harmony TPV and Native studies. Two subjects had the device explanted immediately post-implant. There have been 0 deaths due to device or procedure. Kaplan-Meier Freedom from all-cause mortality in all subjects is 97% at 24 months. Kaplan Meier Freedom from reoperation in all subjects is 96.2% at 24 months.

The most frequent CEC adjudicated procedure-related serious adverse events are: minor hemorrhage: 6.5% (7); Other vascular access site complication: 2.8% (3); Embolization of the TPV: 1.9% (2); Migration of the TPV: 1.9% (2); and minor Paravalvular leak: 1.9% (2).

The most frequent CEC adjudicated device-related serious adverse events are: ventricular tachycardia: 17.8% (19); ventricular premature beats: 8.4% (9); minor paravalvular leak: 5.6% (6); and valve stenosis: 4.7% (5).

Actual Number of Patients Enrolled 420 subjects were enrolled, 87 were catheterized and 86 have been implanted (Harmony TPV study); 66 subjects were enrolled, 21 subjects were catheterized and 20 subjects were implanted (Native TPV Study).

Actual Number of Sites Enrolled 10
Patient Follow-up Rate Eighty-four patients reached the 1-year follow-up window and follow-up was complete for 81 (96.4%) patients (Harmony TPV study).

Final Effect Findings 88.3% (91 subjects) have Acceptable TPV Hemodynamic Function and without valve re-intervention at 6 months. Key measurements of Right Ventricular Remodeling Following TPV Implant such as RVEDV, LVEDV, PRF%, and Net Right ventricular Stroke Volume have improved at 6-months from baseline and continue to improve through 2 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    
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

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