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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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PINNACLE FLX Cont f/u of IDE Cohort


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General
Study Status Completed
Application Number /
Requirement Number		 P130013 S035/ PAS001
Date Original Protocol Accepted 07/21/2020
Date Current Protocol Accepted  
Study Name PINNACLE FLX Cont f/u of IDE Cohort
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 New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
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.
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.
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.
Key Study Endpoints The occurrence of ischemic stroke or systemic embolism at 24 months from the time of implant.
Follow-up Visits and Length of Follow-up 24 months
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.
Actual Number of Sites Enrolled 29
Patient Follow-up Rate 84.3% (386/458) of subjects completed the 2 year visit.
Final Safety Findings N/A
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).
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.
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.


PINNACLE FLX Cont f/u of IDE Cohort Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 01/19/2021 01/21/2021 Overdue/Received
1 year report 07/21/2021 07/16/2021 On Time


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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