Post-Approval Studies (PAS) Database

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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Attain Stability Quad PAS

General
Study Status	Ongoing
Application Number / Requirement Number	P080006 S129/ PAS001
Date Original Protocol Accepted	04/10/2019
Date Current Protocol Accepted
Study Name	Attain Stability Quad PAS
Device Name	Attain Stability Quad MRI SureScan Lead
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	Sponsor Registry
Comparison Group	Concurrent & Historical Control
Analysis Type	Descriptive
Study Population	Adult: >21
Detailed Study Protocol Parameters
Study Objectives	The Medtronic Attain Stability Quad (ASQ) LV Lead Post-Approval Study (PAS) is a nonrandomized, multi-site, world-wide clinical study of implanted commercially available Model 4798 leads. The study is conducted in the US, Canada, Europe (and Asia). All enrolled patients were implanted with a Model 4798 LV Lead and all data is collected prospectively. Data will be collected through Medtronic’s Post Market Surveillance platform and through leveraging extant data including potential use of administrative claims, electronic health records, available registries, and remote monitoring. The study requires a minimum of 1000 leads enolled to satisfy both the primary objective analysis sample size requirement and to estimate individual failure modes at five year post implant for the general population. Attain Stability Quad ISE patients are eligible to continue in the PAS upon market approval is followed at a participating Product Surveillance Registry (PSR) study site and are consented.
Study Population	Patients included in the Model 4798 lead Post Approval Study, were consented and implanted with a Model 4798 LV Lead
Sample Size	The PAS plans to prospectively enroll 1000 subjects through the PSR Sample Size Justification Power 0.864 a 0.05 (two-sided) Success Rate, investigational 95.5% PG 92.5% Attrition 12% per year N 1000
Key Study Endpoints	Primary Objective To demonstrate that the complication-free probability is greater than 92.5% at five years post-implant for Attain Stability Quad LV leads Primary objective analysis includes all complications related to lead hardware or design failure as pre-specified in the Attain Stability Quad Post Approval Study, Analysis Plan (Version 1, 12 Oct 2018) and base protocol of the Product Surveillance Registry (PSR) (Version 6, 7 March 2016). Secondary Objective To summarize all lead related adverse events or Adverse Device Effects (ADEs) To summarize analysis results from explanted and returned Attain Stability Quad leads
Follow-up Visits and Length of Follow-up	All enrolled patients will be followed for 5 years

Attain Stability Quad PAS Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
6 month report	10/10/2019	10/08/2019	On Time
1 year report	04/07/2020	04/03/2020	On Time
18 month report	10/10/2020	10/09/2020	On Time
2 year report	04/10/2021	04/08/2021	On Time
3 year report	04/10/2022	04/07/2022	On Time
4 year report	04/10/2023	04/05/2023	On Time
5 year report	04/10/2024	04/05/2024	On Time
6 year report	04/10/2025

Contact Us

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background