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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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Heartmate 3 Real-World Pediatric Use Surveillance


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General
Study Status Study Pending
Application Number P160054 S031/ PAS001
Date Current Protocol Accepted  
Study Name Heartmate 3 Real-World Pediatric Use Surveillance
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 B (as adults) : 18-21 yrs
Detailed Study Protocol Parameters
Study Design Description Registry-based surveillance. The objective of the surveillance is to continue to monitor the performance of the HeartMate 3 LVAS in pediatric patients.
Study Population Description Pediatric patients with advanced refractory left ventricular heart failure and with an appropriate body surface area who require short- or long-term mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy).



Sample Size All consecutive pediatric patients treated with the HeartMate 3 LVAS within the first 2 years after the PMA approval that are entered into the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) Registry.
Data Collection Patient outcomes (e.g., transplanted, expired, and explanted for recovery) and adverse events at 3, 6, 12, and 24 months.
Follow-up Visits and Length of Follow-up 2 years


Heartmate 3 Real-World Pediatric Use Surveillance Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
One year report 12/17/2021    
Two year report 12/17/2022    
Three year report 12/17/2023    
Four year report 12/17/2024    


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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