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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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HALO PAS


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General
Study Status Progress Adequate
Application Number P810002 S101/ PAS002
Date Current Protocol Accepted  
Study Name HALO PAS
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Neonate: 1-28 days, Infant: 29 days-2 yrs, Child: 2-12 yrs
Detailed Study Protocol Parameters
Study Design Description This PAS is an observational single arm, non-randomized, multi-center clinical trial. Data from patients prospectively and retrospectively enrolled may contribute to the study dataset as follows:
Enrollment of new, prospective patients receiving a 15 AHPJ-505 MHV in the aortic position;
Enrollment of patients previously implanted with a 15AHPJ-505 MHV in the aortic position consenting for retrospective inclusion
Study Population Description Patients requiring aortic valve replacement with anatomy that requires a 15mm valve (< 18 years old)
Sample Size No. of subjects:
A minimum of 20 subjects implanted with the 15mm HP aortic valve (echocardiography data reported whenever it is available); or
A minimum of 12 subjects with echocardiography data at a time point(s) greater than 90 days
No. of sites: 40 sites across US and 10 sites outside of the US
Data Collection Safety Endpoints
Primary:
The actuarial (Kaplan-Meier) rate of total serious valve-related adverse events experienced through 5 years post implant or until the valve is removed/replaced (whether or not the replacement or removal is due to anatomical growth of the subject), whichever occurs first. Valve-related adverse events to be evaluated are:
- Death;
- Endocarditis;
- Hemorrhage (whether or not due to anticoagulant/antiplatelet medication);
- Nonstructural dysfunction (including perivalvular leak, hemolysis, and hemolytic anemia);
- Reoperation (including valve explant, not due to anatomical growth of the subject);
- Structural valve deterioration;
- Thromboembolism; and
- Valvular thrombosis.

Secondary:
-All-cause mortality
-Valve-related mortality
-Reoperation or explant excluding replacement due to somatic growth

Effectiveness Endpoints:
Primary:
- Peak gradient as assessed by echocardiography;
- Mean gradient as assessed by echocardiography;
- Valvular regurgitation type (central or perivalvular) and grade as assessed by echocardiography.

Follow-up Visits and Length of Follow-up Frequency: Baseline, procedure, post procedure, 30D, 6mo, 1 year and annually thereafter
Length: 5 years or explant


HALO PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 09/04/2018 09/06/2018 Overdue/Received
progress report 12/17/2018 12/17/2018 On Time
1 year report 03/06/2019 03/06/2019 On Time
18 month report 09/04/2019 09/06/2019 Overdue/Received
2 year report 03/05/2020 02/28/2020 On Time
3 year report 03/05/2021 03/02/2021 On Time
4 year report 03/05/2022 03/02/2022 On Time
5 year report 03/05/2023    
final report 06/30/2028    


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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