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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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OSB Lead-New Enrollment Study

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Study Status Progress Adequate
Application Number P140017 / PAS002
Date Current Protocol Accepted 01/27/2015
Study Name OSB Lead-New Enrollment Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, non-randomized, multi-center study.
Study Population Description 100 subjects who were successfully implanted in this study

will continue to be followed

Sample Size 100 subjects: Using a power of 80%, an alpha of 5%, a one-

tailed test, and assuming an estimated rate of 86% (the rate found in the premarket study), the required sample size comes out to 81. Therefore, a sample size of 100 with only six months follow-up will ensure that a sufficient number of patients are followed for the entirety of the study.

Data Collection Primary Endpoints

As noted in the study hypothesis, above, the primary endpoint is the percentage of subjects with acceptable hemodynamic function at six months post-implant. Acceptable hemodynamic function is defined as:

¿Þ Mean RVOT gradient less than or equal to 30 mmHg AND

¿Þ Less than moderate severity of pulmonary regurgitation


¿Þ No RVOT conduit reoperation or catheter re-intervention

since implant

Secondary Endpoints

¿Þ Percent patients with procedural success

¿Þ Percent subjects with serious procedural adverse events

¿Þ Percent subjects with serious device-related adverse events at 6 months post-implant

¿Þ Incidence of serious device-related adverse events during full follow-up period

¿Þ Stent fracture

¿Þ Re-intervention on the TPV

¿Þ RVOT conduit reoperation

¿Þ Death

¿X All-cause

¿X Procedure-related

¿X Device-related

¿Þ NYHA classification

Follow-up Visits and Length of Follow-up 5 years

Annually until followed for 5 years

OSB Lead-New Enrollment Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
one year report 01/27/2016 01/27/2016 On Time
two year report 01/26/2017 01/27/2017 Overdue/Received
three year report 01/26/2018    
four year report 01/26/2019    
five year report 01/26/2020    

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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