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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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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 a single arm, non-randomized, multi-center clinical study of the SJMTM Masters HPTM 15mm Rotatable Mechanical Heart Valve (MHV) as aortic valve replacement therapy. The primary objective of this study is to evaluate the long-term safety and effectiveness of the 15mm Masters MHV in patients with a diseased, damaged or malfunctioning aortic valve.
Study Population Description Pediatric patients (< 18 years old) with a diseased, damaged, or malfunctioning aortic valve, needing aortic valve replacement therapy.
Sample Size The study may be conducted to either of the following two options:

1. A minimum of 20 subjects implanted with the 15mm HP aortic valve (echocardiography data reported whenever it is available); or

2. A minimum of 12 subjects with echocardiography data at a time point(s) greater than 90 days.
Data Collection The primary safety endpoint is the 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.

The following effectiveness endpoints will be reported at any and/or all time points available:

- Mean gradient as assessed by echocardiography;

- Peak gradient as assessed by echocardiography; and

- Valvular regurgitation type (central or perivalvular) and grade as assessed by echocardiography.

The hemodynamic parameters described above will be reported at 30 days, 6 months, 1 year and annually after that up to 5 years.

The following additional endpoints will be summarized through 1 year:

- All-cause mortality;

- Valve-related mortality; and

- Reoperation or explant excluding replacement due to somatic growth.

Follow-up Visits and Length of Follow-up Each enrolled subject will be followed for five years from the date of implant, or until device explant.

HALO PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 09/04/2018 09/06/2018 Overdue/Received
progress report 12/17/2018 12/17/2018 On Time
one year report 03/06/2019 03/06/2019 On Time
18 month report 09/04/2019 09/06/2019 Overdue/Received
two year report 03/05/2020 02/28/2020 On Time
three year report 03/05/2021 03/02/2021 On Time
four year report 03/05/2022    
five 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

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