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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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SAPIEN 3 Pulmonic New Enrollment Study-COMPASSION


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General
Study Status Study Pending
Application Number P200015 / PAS002
Date Current Protocol Accepted  
Study Name SAPIEN 3 Pulmonic New Enrollment Study-COMPASSION
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical 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 This is a prospective, multi-center, single-arm new enrollment study. The objective of the study is to monitor the device performance and clinical outcomes of the SAPIEN 3 THV System with Commander Delivery System in the real world for the approved indication.
Study Population Description Pediatric and adult patients who have a clinical indication for intervention on a dysfunctional right ventricular outflow tract (RVOT) conduit or surgical bioprosthetic valve in the pulmonic position with greater than or equal to moderate regurgitation and/or a mean RVOT gradient of greater than or equal to 35 mmHg.
Sample Size 150
Data Collection Device success, THV dysfunction, THV hemodynamic function, and New York Heart Association (NYHA) classification.
Follow-up Visits and Length of Follow-up 5 years


SAPIEN 3 Pulmonic New Enrollment Study-COMPASSION Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 08/31/2021 08/30/2021 On Time
2 year report 08/31/2022    
3 year report 08/31/2023    
4 year report 08/30/2024    


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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