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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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S-ICD PAS Registry


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General
Study Status Completed
Application Number P110042 / PAS001
Date Current Protocol Accepted 09/28/2012
Study Name S-ICD PAS Registry
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 Prospective cohort study
Study Population Description Any patient, who meets the inclusion criteria, does not meet the exclusion criterion and provides informed consent will be enrolled in the registry.
Inclusion Criteria
X Patients eligible for implantation with an S-ICD System, OR patients previously implanted with an S-ICD System Clinical Investigation (IDE G090013)
X Willing and able to provide written informed consent or have informed consent a provided by a legal representative
Exclusion Criterion
X Remaining life expectancy of less than 360 days
Sample Size 1616 patients from approximately 50 investigational centers (up to 150) in the US
Data Collection The primary safety endpoint of the study is the Type I Complication Free Rate at 60 months, which will be compared to a performance criterion

The primary effectiveness endpoint is the Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF through 60 months, which will be compared to a performance criterion.

The secondary safety endpoint of the study is the Electrode-Related Complication Free Rate at 60 months, which will be compared to a performance criterion.

The secondary effectiveness endpoint is First Shock Effectiveness in Converting Induced (Acute) and Spontaneous Discrete Episodes of VT/VF through 60 months, which will be compared to a performance criterion.
Follow-up Visits and Length of Follow-up Data will be collected through the 60th month (1800 days) post implant.
Data will be collected from each patient at enrollment, implant, annual follow-up visits and from unscheduled follow up visits associated with system/procedure-related complications or spontaneous episodes.
Interim or Final Data Summary
Actual Number of Patients Enrolled 1766
Actual Number of Sites Enrolled 86
Patient Follow-up Rate The mean follow-up duration was 40.4 months 43.6% of the subjects completed the study. 11.0% of the subjects were lost to follow-up
Final Safety Findings PRIMARY SAFETY:
Type I Complication Free Rate at 60 months passed the complication free rate at lower one-sided 95% confidence bound of 91.4%. This was
above the performance criteria set at 85%
SECONDARY SAFETY:
The Electrode-Related Complication Free Rate at 60 months (1800 days) passed the performance goal of 92.5% with a lower one-sided
95% confidence bound of 98.8%.
Final Effect Findings PRIMARY EFFECTIVENESS:
The Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF through 60 months passed the performance goal of
94% with a lower one-sided 95% confidence bound of 97.4%.
SECONDARY EFFECTIVENESS:
First Shock Effectiveness in Converting Induced (Acute) and Spontaneous Discrete Episodes of VT/VF through 60 months passed the
performance goal of 84% with lower one-sided 95% confidence bound of 94.1% for induced episodes and 89.8% for spontaneous discrete
episodes.
Study Strengths & Weaknesses The safety and effectiveness primary and secondary endpoints were all acceptable. The additional pre-specified endpoints were favorable.
Recommendations for Labeling Changes The results of the study are acceptable and should be added to the device labeling


S-ICD PAS Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 03/29/2013 03/27/2013 On Time
one year report 09/28/2013 09/26/2013 On Time
18 month report 03/29/2014 03/26/2014 On Time
two year report 10/06/2014 10/01/2014 On Time
three year report 09/28/2015 09/25/2015 On Time
four year report 09/27/2016 09/26/2016 On Time
five year report 10/06/2017 10/04/2017 On Time
six year report 09/28/2018 09/26/2018 On Time
seven year report 09/28/2019 09/27/2019 On Time
eight year report 09/28/2020 09/28/2020 On Time
final report 12/17/2021 12/16/2021 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

Additional Resources

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