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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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Extended Phase BeAT-HF PAS


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General
Study Status Progress Adequate
Application Number P180050 / PAS001
Date Current Protocol Accepted  
Study Name Extended Phase BeAT-HF PAS
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs
Detailed Study Protocol Parameters
Study Design Description The study is continued follow up of the IDE cohort with additional enrollments post-approval to determine if the device can reduce cardiovascular mortality and heart failure hospitalizations.
Study Population Description For patients who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction less than or equal to 35%, a NT-proBNP < 1600 pg/ml and excluding patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines
Sample Size 480 subjects
Data Collection Rate of events (cardiovascular death and/or heart failure hostpitalization) is lower in treatment arm than control arm.
Follow-up Visits and Length of Follow-up Follow-up continues to post-approval study completion.
Interim or Final Data Summary
Actual Number of Patients Enrolled 457 randomized
Actual Number of Sites Enrolled 62
Patient Follow-up Rate N/A
Final Safety Findings N/A


Extended Phase BeAT-HF PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 02/14/2020 02/19/2020 Overdue/Received
one year report 08/15/2020    
18 month report 02/13/2021    
two year report 08/15/2021    
three year report 08/15/2022    
four year report 08/15/2023    
five year report 08/14/2024    


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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