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|
| General |
| Study Status |
Ongoing |
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
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
97,185 subjects
Implant success: 97.5% (94784/97185)
|
| Actual Number of Sites Enrolled |
N/A – All sites entered into LAAO registry
|
| Patient Follow-up Rate |
Intent to treat cohort (ITT) follow-up rates:
45 day - 89.6%
6 month - 62.2%
12 month - 47.1%
24 month - 16%
|
| Final Safety Findings |
Occurrence 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 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: 0.45% (ITT cohort)
|
| Final Effect Findings |
Occurrence of ischemic stroke or systemic embolism at 24 months post-implant: 0.35% (ITT cohort)
|
