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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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SURPASS Pro


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General
Study Status Study Pending
Application Number /
Requirement Number
P130013 S057/ PAS001
Date Original Protocol Accepted 10/31/2023
Date Current Protocol Accepted  
Study Name SURPASS Pro
Device Name WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives SURPASS Pro is an observational, prospective, non-randomized, multicenter registry surveillance analysis plan for all patients entered into the LAAO Registry who had a WATCHMAN FLX Pro Device implant attempt. This surveillance is designed to monitor data including: .
ischemic stroke and systemic embolism at hospital discharge, 45 days, 6 months, 12 months, and 24 months post-procedure. The surveillance should also monitor the rate of 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 within seven days of the procedure or by hospital discharge, whichever is later.
Study Population SURPASS Pro data will include all patients enrolled in the LAAO Registry who had a WATCHMAN FLX Pro Device implant attempt and were discharged between Q4 2023 to Q4 2025.
As appropriate, subgroup analyses may be performed. These analyses may include (but are not limited to) endpoint evaluation for the following subgroups:
• IFU/Indication compliant implants
• Post-implant drug regimens
• Sex/gender
• Race/ethnicity
Sample Size Data will be captured from all LAAO Registry participating sites in the United States The estimated number of subjects for this study is approximately 30,000
Key Study Endpoints Safety Endpoints
Primary:
• The occurrence of one of the following events between the time of the first implant procedure and within seven days of the procedure or by hospital discharge, whichever is later:
o All-cause death,
o Ischemic stroke,
o Systemic embolism, or
o 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.
Percutaneous catheter drainage of pericardial effusions, snaring of an embolized device, thrombin injection to treat femoral pseudoaneurysm and nonsurgical treatments of access site complications are excluded from this endpoint and will be reported separately.
Secondary: Additional analyses will include occurrence of the following endpoints at each LAAO Registry follow-up time points (discharge, 45 days, 6 months, 12 months, and 24 months post-procedure):
• All-cause death
• All stroke
• Ischemic stroke
• Hemorrhagic stroke
• Device-related thrombus (DRT)
• Systemic thromboembolism
• Major bleeding
• Device embolism
These endpoints will be analyzed descriptively.
Effectiveness Endpoints
Primary: The occurrence of ischemic stroke or systemic embolism at 24 months post-implant
Secondary: Additional analyses will include occurrence of the following endpoints at each LAAO Registry follow-up time points (discharge, 45 days, 6 months, 12 months, and 24 months post-procedure):
• Effective device closure
o Note: Effective device closure is measured via LAAO Registry DCF field “Device Margin Residual Leak”. Effective device closure is defined as “Complete Seal” or 0 < Device Margin Residual leak (mm) less than or equal to 5mm.
• Implant success (defined as device release and deployed)
These endpoints will be analyzed descriptively.
Follow-up Visits and Length of Follow-up The LAAO Registry will collect data at baseline, procedure, discharge, and at follow-up visits: 45 days, 6 months, 12 months, and 24 months post-procedure. Patients will be followed for 2 years.


SURPASS Pro Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 03/06/2024    
1 year report 09/05/2024    
18 month report 03/06/2025    
2 year report 09/05/2025    
3 year report 09/05/2026    
4 year report 09/05/2027    


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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