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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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ODE Lead-ACUITY X4 Post Approval Study


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General
Study Status Progress Adequate
Application Number P010012 S398/ PAS001
Study Name ODE Lead-ACUITY X4 Post Approval Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The ACUITY X4 Lead PAS aims to follow the current IDE cohort of patients to assess long-term lead performance.
Study Population Description The ACUITY X4 quadripolar coronary venous leads are intended for chronic left ventricular pacing and sensing when used in conjunction with a compatible pulse generator. The study population includes subjects indicated for CRT-D therapy.
Sample Size A total of 2290 subjects will be enrolled in the IDE study, with 2134 subjects (93.2% implant rate) having an ACUITY X4 lead. It is projected that at least 1169 (54.8% likely to continue full follow up) subjects will be followed for 5 years. The primary safety endpoint can be achieved with a minimum sample size of 245 leads with an expected performance goal of 97.8%.
Data Collection The primary endpoint is to achieve a complication free rate of 92.5%. The firm will report adverse events, deaths, device deficiencies, protocol deviations, lead measurements and visit compliance. Additionally, the firm will conduct hazard analyses using the Weibull regression models to determine a hazard rate for the ACUITY X4 leads. A pooling analysis will be conducted to adjust any imbalances in the cohort analyses and center-to-center heterogeneity.
Follow-up Visits and Length of Follow-up 5 years


ODE Lead-ACUITY X4 Post Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/22/2016 08/19/2016 On Time
one year report 02/21/2017 02/21/2017 On Time
18 month report 08/22/2017 08/09/2017 On Time
two year report 02/21/2018    
three year report 02/21/2019    
four year report 02/21/2020    
five year report 02/20/2021    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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