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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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ODE Lead-COMPASSION Cohort


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General
Study Status Progress Adequate
Application Number P130009 S037/ PAS001
Study Name ODE Lead-COMPASSION Cohort
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
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 Design Description Continued follow-up of all living subjects who were enrolled under the IDE (G060242). The objective of this PAS is to characterize the clinical outcomes annually through 5 years post-procedure.
Study Population Description All living subjects who were enrolled in the IDE
Sample Size All living subjects
Data Collection The safety and effectiveness endpoints include freedom from device- or procedure-related death or reintervention, freedom from MACCE,

functional improvement (decrease in pulmonary regurgitation, improvement in NYHA functional class, freedom from recurrent pulmonary stenosis), procedural- and device-related adverse events, stent fracture, reintervention on the THV or conduit, and death.

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

All subjects are followed at 30 days, 6 months, 12 months, and annually thereafter through 5 years post procedure


ODE Lead-COMPASSION Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/29/2016 08/29/2016 On Time
one year report 02/28/2017 02/28/2017 On Time
18 month report 08/29/2017 08/29/2017 On Time
two year report 02/28/2018    
three year report 02/28/2019    
four year report 02/28/2020    
five year report 02/27/2021    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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