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General |
Study Status |
Completed |
Application Number / Requirement Number |
P130013 S035/ PAS001 |
Date Original Protocol Accepted |
07/21/2020
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Date Current Protocol Accepted |
 
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Study Name |
PINNACLE FLX Cont f/u of IDE Cohort
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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 |
New Data Collection
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Comparison Group |
Objective Performance Criterion
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Analysis Type |
Analytical
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Study Population |
Adult: >21
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Detailed Study Protocol Parameters |
Study Objectives |
Continued follow up of the premarket cohort in the prospective, single arm PINNACLE FLX trial. The study objective is to characterize the safety and effectiveness of the WATCHMAN FLX LAA Closure Device with Delivery System through 24 months post-procedure.
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Study Population |
The study consists of all IDE patients who are currently enrolled and alive and are eligible for the secondary effectiveness endpoint evaluation. The secondary effectiveness endpoint is defined in the protocol as the occurrence of ischemic stroke or systemic embolism at 24 months from the time of implant.
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Sample Size |
Initial enrollment in the PINNACLE FLX study was 458 subjects (400 in the main cohort and 58 in the roll-in cohort). Of these 458 subjects, 425 subjects are potentially available for 24 month follow up.
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Key Study Endpoints |
The occurrence of ischemic stroke or systemic embolism at 24 months from the time of implant.
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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 |
Initial enrollment in the PINNACLE FLX study was 458 subjects (400 in the main cohort and 58 in the roll-in cohort). Of these 458 subjects, 425 subjects were potentially available for 24 month follow up.
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Actual Number of Sites Enrolled |
29
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Patient Follow-up Rate |
84.3% (386/458) of subjects completed the 2 year visit.
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Final Safety Findings |
N/A
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Final Effect Findings |
The 24-month ischemic stroke or systemic embolism rate was 3.4%. This is below the prespecified performance goal of 8.7% (upper one-sided 95% confidence limit was 5.3%; P<0.001).
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Study Strengths & Weaknesses |
A strength of the study is that it provided results on the longer term (2 years) safety and efficacy of the device.
A weakness of the PINNACLE FLX study is that this study is a single arm (non-randomized) study.
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Recommendations for Labeling Changes |
A labeling change is recommended to add the 24 month safety and efficacy results from the pre-market cohort into the label.
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