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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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OSB Lead-WATCHMAN Comprehensive/Linked-Registry


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General
Study Status Progress Adequate
Application Number P130013 / PAS003
Date Current Protocol Accepted 11/30/2016
Study Name OSB Lead-WATCHMAN Comprehensive/Linked-Registry
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source External Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This Novel Surveillance plan is designed to monitor registry collected data including the following: implant success rate, procedural safety, effective closure of the orifice of the left atrial appendage, and stroke through two years post implant and CMS identification of adverse events of interest and death from two through five years post implant. Patients from a subgroup analysis will have their outcomes compared to pre- specified performance goals for the following: occurrence of composite of stroke (including ischemic or hemorrhagic), systemic embolism, and all cause death at 24 months from the time of implant. The second endpoint is the occurrence of ischemic stroke or systemic embolism at 24 months from the time of implant. The third endpoint is the occurrence of any of the following events within seven days of the implant procedure or by hospital discharge, whichever is later: all cause death, ischemic stroke, systemic embolism, or device or procedure related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair.

Study Population Description Patients with attempted implant of the WATCHMAN device enrolled at sites participating in the LAAO registry.
Sample Size A minimum of 2000 patients implanted with the WATCHMAN device. At least 1000 of the patients will be match the Indications for Use for the WATCHMAN device. Another 1000 patients will be eligible for the WATCHMAN device, have CHADS score of two or greater or a CHA DS -VASc score of

2 2 2

three or greater, and do not have a concomitant cardiac or

non-cardiac procedure.



Data Collection Study Endpoints

Overall surveillance will monitor implant success rate, procedural safety, effective closure of the orifice of the left atrial appendage, and stroke (ischemic or hemorrhagic) through two years post-implant and CMS claims identified occurrence of all stroke (ischemic or hemorrhagic).



For the subgroup analysis the Primary Endpoints follow.



Primary Endpoint 1. The occurrence of the composite stroke (ischemic or hemorrhagic), systemic embolism, and all cause death at 24 months from the time of implant.



Primary Endpoint 2. The occurrence of ischemic stroke or systemic embolism at 24 months from the time of implant.



Primary Endpoint 3. The occurrence of any of the following events within seven days of the procedure or by hospital discharge whichever is later: all cause death, ischemic stroke systemic embolism, or device or procedure realted events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair.

Follow-up Visits and Length of Follow-up Patients will be followed through five years post implant.


OSB Lead-WATCHMAN Comprehensive/Linked-Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
FDA 6 month report 09/11/2015 09/17/2015 Overdue/Received
FDA one year report 03/12/2016 03/11/2016 On Time
FDA 18 month report 01/10/2017 01/10/2017 On Time
FDA two year report 03/31/2017 03/31/2017 On Time
FDA 30 month report 09/30/2017 09/27/2017 On Time
FDA three year report 03/31/2018    
FDA 42 month report 09/30/2018    
FDA four year report 03/31/2019    
FDA 54 month report 09/30/2019    
FDA five year report 03/31/2020    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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