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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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GORE CARDIOFORM New Enrollment PAS


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General
Study Status Progress Adequate
Application Number /
Requirement Number
P050006 S060/ PAS002
Date Original Protocol Accepted 12/07/2018
Date Current Protocol Accepted 07/06/2022
Study Name GORE CARDIOFORM New Enrollment PAS
Device Name GORE CARDIOFORM Septal Occluder
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives Single-arm, prospective, new enrollment, multi-center study. The objective is to assess and confirm the safety
and effectiveness of the Gore Septal Occluder (GSO) device. This device was evaluated in the REDUCE
pivotal IDE study. This study is to evaluate the quality of perator education and training, and transferability of
trail experience to a post-market setting.
Study Population 18-70 years of age with a Patent Foramen Ovale (PFO) who have experienced an embolic stroke of undetermined source in the past year.
Sample Size At least 636 patients with a limit of 10% (~63) patients will be allowed to be 61-70 years of age at the time of
enrollment. Currently 40 eligible sites in the US.

Key Study Endpoints Primary Effectiveness Endpoint:
The proportion of subjects with ischemic stroke at 2 years in subjects with the study device implanted.
This will be compared to a performance goal (PG) of 3.8%.
Primary Safety Endpoint:
The cumulative incidence of device- or procedure-related serious adverse events through 30 days. This will be compared to a PG of 6.4%.
Secondary Effectiveness Endpoint:
Effective PFO Closure – Proportion of subjects with complete PFO closure or a trivial or small residual shunt, at 1 year.
The secondary endpoints for this study include:
• Clinically Significant New Atrial Arrhythmia
• Clinically Significant New Atrial Arrhythmia by Age
• Technical Success
• Residual Shunt Characterization
• Procedural Success


Follow-up Visits and Length of Follow-up Follow ups at 1, 6, 12 and 24 months. Over the phone follow up out to 60 months.


GORE CARDIOFORM New Enrollment PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 09/28/2018 09/20/2018 On Time
1 year report 03/30/2019 03/20/2019 On Time
18 month report 09/28/2019 09/23/2019 On Time
2 year report 03/29/2020 03/24/2020 On Time
3 year report 03/29/2021 03/23/2021 On Time
4 year report 03/29/2022 03/25/2022 On Time
5 year report 03/29/2023    


Contact Us

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

Additional Resources

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