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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P130013 S074/ PAS002 |
| Date Original Protocol Accepted |
12/15/2025
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| Date Current Protocol Accepted |
12/15/2025
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| Study Name |
WATCHMAN FLX Pro NOAC Alone PAS
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| Device Name |
WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System, WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System
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| Clinical Trial Number(s) |
NCT02699957
NCT03795298
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| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
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| Data Source |
External Registry
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is an observational, prospective, non-randomized, multicenter registry surveillance analysis designed to characterize clinical outcomes and to assess the real-world use of the commercial WATCHMAN FLX Pro LAA Closure Device with Delivery System. The analysis is designed to assess safety outcomes associated with the use of non-vitamin K oral anticoagulant (NOAC) alone as an alternative to an oral anticoagulant (OAC) and aspirin as the post-implant medication regimen for the WATCHMAN FLX Pro Left Atrial Appendage (LAA) Closure Device with Delivery System in a routine clinical setting. Data will be captured from the Left Atrial Appendage Occlusion (LAAO) Registry within the American College of Cardiology Foundation’s (ACCF) National Cardiovascular Data Registry (NCDR) conducted in the United States.
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| Study Population |
LAAO registry subjects who were successfully implanted with a WATCHMAN FLX Pro device, discharged 6 months prior to the NOAC alone labeling change implementation (16Jan2025 to 16Jul2025) or 6 months post labeling change implementation (17Jul2025 to 17Jan2026), and who meet inclusion/exclusion criteria.
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| Sample Size |
Number of subjects: N/A. See above study population
Assumptions for sample size estimation: N/A
Number of sites: Data from all sites participating in the LAAO Registry in the United States will be used for the analysis.
Sites location: US
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| Key Study Endpoints |
Co-Primary Endpoint: Composite Endpoint
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 successfully implanted subjects between the date of hospital discharge and 45 days post-implant procedure and between hospital discharge and 6 months post-implant procedure.
Co-Primary Endpoint: Safety Endpoint
The occurrence of one of the following events between the time of the first implant attempt procedure and within seven days of that 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.
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.
Co-Primary Endpoint: Effectiveness Endpoint
The occurrence of ischemic stroke or systemic embolism at 24 months post-implant procedure.
Additional Endpoints
Additional analyses will include the evaluation of the following events prior to and after the NOAC alone labeling implementation.
Clinical events will be assessed between hospital discharge and 45 days, 6 months, 12 months and 24 months post-implant procedure:
• All-cause death
• Cardiovascular death
• All stroke
• Ischemic stroke
• Hemorrhagic stroke
• Systemic thromboembolism
• Major bleeding
• Pericardial effusion
• Device embolization
• Device margin residual leak
• Device-related thrombus
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| Follow-up Visits and Length of Follow-up |
Subjects in all cohorts will be followed at hospital discharge, 45 days, 6 months, 12 months and 24 months post-implant procedure.
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