f Post-Approval Studies (PAS) Database
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

  • Print
  • Share
  • E-mail
-

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 LAA Closure Device w/Delivery RW Use


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Progress Adequate
Application Number /
Requirement Number
P130013 S035/ PAS002
Date Original Protocol Accepted 05/21/2021
Date Current Protocol Accepted  
Study Name WATCHMAN FLX LAA Closure Device w/Delivery RW Use
Device Name WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Left Atrial Appendage Closure Device with Delivery System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Objective Performance Criterion
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives The WATCHMAN FLX Device Surveillance Post Approval Analysis is an observational, prospective, nonrandomized,
multicenter registry surveillance analysis plan using real world data. The study is designed to assess long-term safety and effectiveness outcomes
associated with the use and implantation of the WATCHMAN FLX Left Atrial Appendage (LAA) Closure Device with Delivery System in a routine clinical setting. This surveillance analysis will utilize data captured in the Left Atrial Appendage Occlusion Registry (LAAO Registry) within the American College of Cardiology Foundation’s (ACCF) National Cardiovascular Data Registry (NCDR).
Study Population The study consists of all subjects enrolled in the LAAO Registry for the first two years.
Sample Size Estimated enrollment is 30,000 subjects
Key Study Endpoints The surveillance will be carried out to characterize clinical outcomes (including: implant success rate, procedural safety, effective closure of the orifice of the left atrial appendage, and stroke [including ischemic or hemorrhagic] through one- year post-implant] and longer term identified occurrence of all stroke (including ischemic or hemorrhagic) and to assess the real-world use of the commercial WATCHMAN FLX LAA Closure Device with Delivery System.
Follow-up Visits and Length of Follow-up 24 months


WATCHMAN FLX LAA Closure Device w/Delivery RW Use Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 01/19/2021 01/21/2021 Overdue/Received
1 year report 07/21/2021 07/21/2021 On Time
18 month report 01/19/2022 01/19/2022 On Time
2 year report 07/21/2022 07/20/2022 On Time
3 year report 07/21/2023    


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

-
-