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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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Study Status Progress Adequate
Application Number P050006 S060/ PAS002
Date Current Protocol Accepted 12/07/2018
Study Name GORE CARDIOFORM New Enrollment PAS
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 Design Description This is a hypothesis driven, single-arm, prospective, new enrollment, multi-center study. The objective of the study to assess and confirm the safety and effectiveness of the Gore Septal Occluder (GSO) device as observed in the REDUCE pivotal IDE study, and to evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.
Study Population Description Patients between 18 and 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 A minimum of 636 subjects will be enrolled, and a limit of 10 percent of subjects will be between the ages of 61 and 70 at enrollment.

The sample size was determined to account for an expected 10 percent attrition by two years of follow-up. This sample size provides 80 percent power for the primary safety and the primary effectiveness hypothesis assessment. The allowed one-sided type one error is 0.05 for both the primary safety and primary effectiveness hypotheses.

Data Collection Primary Safety Endpoint: The cumulative incidence of device- or procedure-related serious adverse events through 30 days post-implant.

Primary Effectiveness Endpoint: The proportion of subjects with an incident ischemic stroke during two years post-implant, among subjects with a successful device implant

Secondary Effectiveness Endpoint: The proportion of subjects with a complete PFO closure or a trivial or small residual shunt, at one year post-implant.

The primary safety and effectiveness endpoints will also be stratified by operator experience.

Additional endpoints: Cumulative incidence of clinically significant new atrial arrhythmia (stratified by age group) and cumulative incidence of technical success of procedure and implant. Characterization of Residual Shunt in all subjects implanted successfully.

Follow-up Visits and Length of Follow-up Subjects will be followed through five years post-implant.

GORE CARDIOFORM New Enrollment PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 09/28/2018 09/20/2018 On Time
one year report 03/30/2019 03/20/2019 On Time
18 month report 09/28/2019    
two year report 03/29/2020    
three year report 03/29/2021    
four year report 03/29/2022    
five 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

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