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General |
Study Status |
Ongoing |
Application Number / Requirement Number |
P130013 S035/ PAS002 |
Date Original Protocol Accepted |
05/21/2021
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Date Current Protocol Accepted |
 
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Study Name |
WATCHMAN FLX LAA Closure Device w/Delivery RW Use
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Device Name |
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Left Atrial Appendage Closure Device with Delivery System
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Clinical Trial Number(s) |
NCT02702271
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General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
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Data Source |
External Registry
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Comparison Group |
Objective Performance Criterion
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Analysis Type |
Descriptive
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Study Population |
Adult: >21
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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).
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Study Population |
The study consists of all subjects enrolled in the LAAO Registry for the first two years.
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Sample Size |
Estimated enrollment is 30,000 subjects
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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.
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Follow-up Visits and Length of Follow-up |
24 months
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Interim or Final Data Summary |
Actual Number of Patients Enrolled |
Enrollment is complete as of September 30, 2022. A total of 97,529 ITT subjects have been enrolled over the course of the full 24-month enrollment period.
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Actual Number of Sites Enrolled |
N/A – All sites entered into LAAO registry
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Patient Follow-up Rate |
Intent to treat follow-up rates: 45 day – 91.2% 6 month – 81.2% 12 month – 74.6% 24 month – 43.1%
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Final Safety Findings |
As of this progress report, 0.46% (451/97,529) / 0.41% (388/95,125) of the subjects have had 1 or more key safety events in the ITT/Implanted data sets, respectively.
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Final Effect Findings |
In the Implant data set to-date, the adjudicated rates of ischemic stroke or systemic embolism was 0.04% at discharge, 0.13% at 7 days, 0.25% at 45 days, 0.71% at 182 days, 1.34% at 365 days, and 2.46% at 730 days (Kaplan-Meier estimates). In the Intent to Treat data set-to-date ischemic stroke or systemic embolism was 0.05% at discharge, 0.13% at 7 days, 0.25% at 45 days, 0.71% at 182 days, 1.34% at 365 days, and 2.46% at 730 days (Kaplan-Meier estimates).
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