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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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Impella CPSA/5.5 Real-World Pediatric Use Surv


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General
Study Status Study Pending
Application Number /
Requirement Number		 P140003 S111/ PAS001
Date Original Protocol Accepted 12/03/2024
Date Current Protocol Accepted 12/03/2024
Study Name Impella CPSA/5.5 Real-World Pediatric Use Surv
Device Name Impella CP with SmartAssist, Impella 5.5 with SmartAssist
General Study Protocol Parameters
Study Design Active Surveillance
Data Source External Registry
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 Objectives Continue monitoring the performance of the Impella CP with SmartAssist and Impella 5.5 with SmartAssist systems in pediatric patients through the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) Registry.
Study Population Consecutive pediatric patients treated with the two systems that are entered into the ACTION Registry.
Sample Size A total of 60 patients, with a minimum of 20 patients treated with Impella 5.5 with SmartAssist.
Key Study Endpoints Survival and adverse events.
Follow-up Visits and Length of Follow-up Through device explant


Impella CPSA/5.5 Real-World Pediatric Use Surv Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 06/03/2025 06/03/2025 On Time
1 year report 12/03/2025    
2 year report 12/03/2026    
3 year report 12/03/2027    
4 year report 12/02/2028    


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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