Post-Approval Studies (PAS) Database

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.

Learn more...

WATCHMAN FLX NESTed DAPT PAS

General
Study Status	Ongoing
Application Number / Requirement Number	P130013 S043/ PAS001
Date Original Protocol Accepted	10/28/2022
Date Current Protocol Accepted	03/25/2026
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: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives	The WATCHMAN FLXTM DAPT Post Approval Analysis is designed to assess safety outcomes associated with the use of dual antiplatelet therapy (DAPT) as an alternative to an oral anticoagulant (OAC) and aspirin as the post-implant medication regimen for the WATCHMAN Left Atrial Appendage (LAA) Closure Technology in a routine clinical setting. Data will be captured from the Left Atrial Appendage Occlusion Registry (LAAO Registry) within the American College of Cardiology Foundation’s (ACCF) National Cardiovascular Data Registry (NCDR) conducted in the United States.
Study Population	All adults implanted with a WATCHMAN FLX device and prescribed DAPT at discharge
Sample Size	~5600 patients expected
Key Study Endpoints	The composite event rate is defined as all-cause death, stroke (ischemic and/or hemorrhagic), major bleeding, and systemic embolism. The composite event endpoint will be assessed in subjects who were successfully implanted between the date of hospital discharge and 45 days and between hospital discharge and 6 months post-procedure. Additional analyses will include evaluation of the proportion of the following individual events between the date of hospital discharge, 45 days, and 6 months post-procedure prior to and post DAPT labeling implementation: *All death *All stroke *Ischemic stroke *Hemorrhagic stroke *Device-related thrombus *Systemic thromboembolism *Major bleeding *Device margin residual leak *Device embolization
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	03/28/2024	On Time
final report	05/01/2026	04/29/2026	On Time

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

---

• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background