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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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iATP PAS


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General
Study Status Progress Adequate
Application Number P980016 S713/ PAS001
Date Current Protocol Accepted  
Study Name iATP PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs
Detailed Study Protocol Parameters
Study Design Description To further characterize iATP effectiveness in real world clinical practice to pace-terminate VT. The study is a global, non-randomized, prospective post-market surveillance study.
Study Population Description Subjects with an implanted Cobalt ICD or CRT-D with iATP enabled and enrolled in the Medtronic CareLink Network.
Sample Size Approximately 2200 patients will be enrolled to review 241 eligible episodes.
Data Collection To demonstrate the effectiveness performance of iATP in the fast VT (FVT) zone is acceptable, i.e. iATP success rate is greater than 60%.

Secondary objectives:
To demonstrate the effectiveness performance of iATP in the FVT zone exceeds expectations, i.e., iATP success rate is greater than 70%
To characterize arrhythmia-related syncope events
To characterize unnecessary and inappropriate shocks
Follow-up Visits and Length of Follow-up 5 years
Interim or Final Data Summary
Interim Safety Information 123 spontaneous episodes were collected in one of the ventricular tachycardia zones (VT, VF, FVT), where one or more ATP (traditional ATP and/or iATP) therapies were delivered and EGM was available. Of them, 20 spontaneous episodes detected in the FVT zone were treated with iATP and EGM was available. As of the cut-off date, zero episodes have not been adjudicated by ERC. 3 syncope events have been reported; however, still need to be reviewed by the ERC – all were resolved. There have been 7 deaths, unrelated to the device.
Actual Number of Patients Enrolled 281
Actual Number of Sites Enrolled 34
Patient Follow-up Rate 95.47%


iATP PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 10/22/2020 10/21/2020 On Time
1 year report 04/23/2021 04/22/2021 On Time
18 month report 10/22/2021 10/21/2021 On Time
2 year report 04/23/2022 04/19/2022 On Time
3 year report 04/23/2023    


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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