f Post-Approval Studies (PAS) Database
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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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Extended Phase BeAT-HF PAS


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General
Study Status Completed
Application Number /
Requirement Number		 P180050 / PAS001
Date Original Protocol Accepted 08/16/2019
Date Current Protocol Accepted 01/20/2023
Study Name Extended Phase BeAT-HF PAS
Device Name BAROSTIM NEO® System
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 Objectives 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 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
Key Study Endpoints 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.


Extended Phase BeAT-HF PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 02/14/2020 02/19/2020 Overdue/Received
1 year report 08/15/2020 08/28/2020 Overdue/Received
18 month report 02/13/2021 02/23/2021 Overdue/Received
2 year report 02/13/2022 02/18/2022 Overdue/Received
3 year report 02/13/2023 02/17/2023 Overdue/Received
final report 02/13/2024 03/01/2024 Overdue/Received


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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