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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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OPTIMIZER System PAS


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General
Study Status Study Pending
Application Number P180036 / PAS001
Study Name OPTIMIZER System PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Detailed Study Protocol Parameters
Study Design Description This PAS is a prospective, multi-center, non-randomized, single arm open label study of 620 subjects receiving an Optimizer implant as standard of care. The study hypothesis is that CCM meaningfully improves health outcomes in patients implanted with the OPTIMIZER Smart and is safe to use in a real-world setting.
Study Population Description Patients to be included will have NYHA functional class III symptoms and reduced (HFrEF) or moderately reduced (HFmrEF) ejection fraction (25-45% inclusive and are not indicated for Cardiac Synchronization Therapy (CRT).
Sample Size The study is powered for the safety endpoint defined as a composite adverse event count including both short-term procedural complications and long-term device complications. The proportion of patients who are free of procedural and device complications will be compared to an objective performance criterion. With 620 patients (589 evaluable) at one year, the study will have 90% power to demonstrate a complication free rate greater than 0.75 if the assumed complication free rate is 0.81 allowing for 5% lost to follow-up at 1 year. This calculation is based on a one-sided Type I error of 0.025. With 589 evaluable patients at 1 year, if the observed complication free rate is as low as 0.79 then the null hypothesis will be rejected. To account for a 20% expected attrition rate through 3 years, 620 subjects will be enrolled in the PAS study to ensure 500 subjects complete the study. With 500 patients, if the observed complication free rate at the end of the study is as low as 0.79 then a similar test of the null hypothesis would be rejected.
Data Collection Safety: Demonstrate that the OPTIMIZER Smart is safe to use, by assessing the rate of device- or procedure-related complications.

Effectiveness: Demonstrate that CCM therapy improves quality of life (QOL), the functional status of NYHA III patients. In addition, assess CCM effect on left ventricular ejection fraction (LVEF),end-systolic volume (ESV), NT-proBNP and QRS Duration.

Follow-up Visits and Length of Follow-up 36 months


OPTIMIZER System PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/19/2019 09/13/2019 On Time
one year report 03/20/2020    
18 month report 09/18/2020    
two year report 03/20/2021    
three year report 03/20/2022    
four year report 03/20/2023    


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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