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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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Attain Stability Quad PAS


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General
Study Status Progress Adequate
Application Number P080006 S129/ PAS001
Date Current Protocol Accepted  
Study Name Attain Stability Quad PAS
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 Design Description 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 Description 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



Data Collection 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
Interim or Final Data Summary
Interim Safety Information Safety: As of the report cut off date, there have been four (4) 4798-related events reported. All 4 were reviewed by the CEC. One (1) was adjudicated as Model 4798 related complications and three (3) events were classified as observations.

Effectiveness: The sponsor states that to date, no patients have experienced an abnormal pacing impedance. There are 7 leads with elevated

thresholds. There were no occurrences of pacing threshold measurements which met the definition of a threshold rise and were subsequently adjudicated by the CEC as a complication.
Actual Number of Patients Enrolled 132
Actual Number of Sites Enrolled 28
Patient Follow-up Rate 87.32%
Study Strengths & Weaknesses Study appears to be adequately progressing


Attain Stability Quad PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/10/2019 10/08/2019 On Time
one year report 04/07/2020 04/03/2020 On Time
18 month report 10/10/2020    
two year report 04/10/2021    
three year report 04/10/2022    
four year report 04/10/2023    


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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