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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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WATCHMAN FLX NESTed DAPT PAS


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General
Study Status Study Pending
Application Number /
Requirement Number
P130013 S043/ PAS001
Date Original Protocol Accepted 10/28/2022
Date Current Protocol Accepted  
Study Name WATCHMAN FLX NESTed DAPT PAS
Device Name WATCHMAN™ and WATCHMAN FLX™ Left Atrial Appendage Closure Devices with Delivery Systems
General Study Protocol Parameters
Study Design Active Surveillance
Data Source External Registry
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Comprehensive/Linked/Registry Based Surveillance
Study Population All adults implanted with a WATCHMAN FLX device and prescribed DAPT at discharge
Sample Size ~5600 patients expected
Key Study Endpoints Primary Endpoint: Adverse event rates between date of hospital discharge, 45-days post-procedure and 6 months post-procedure will be compared between the DAPT, DOAC and warfarin cohorts for patients implanted with a WATCHMAN FLX device between August 2021 and September 2022 (prior to NESTed DAPT labeling implementation) and October 2022 through September 2023.
Additional Endpoints: Additional analyses will include occurrence of the following endpoints at LAAO Registry Follow-up time points:
All Death
All Stroke
Ischemic Stroke
Hemorrhagic Stroke
Device-Related Thrombus (DRT)
Systemic Thromboembolism
Major Bleed
Device Margin Residual Leak
Follow-up Visits and Length of Follow-up All cohorts will be followed between date of hospital discharge and 45-day post-procedure (October 2022 [date of NESTed DAPT labeling implementation] through September 2023) and between discharge, 45 days and 6 months (August 2021 and September 2022 [date prior to NESTed DAPT labeling implementation])


WATCHMAN FLX NESTed DAPT PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
interim report 03/31/2024    
final report 03/31/2025    


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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