f Post-Approval Studies (PAS) Database
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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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OPTIMIZER System PAS


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General
Study Status Progress Adequate
Application Number /
Requirement Number
P180036 / PAS001
Date Original Protocol Accepted 03/21/2019
Date Current Protocol Accepted 09/06/2022
Study Name OPTIMIZER System PAS
Device Name OPTIMIZER Smart System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives Prospective, non-randomized, multi-center, single-arm open label study to provide long-term safety and effectiveness data.
Study Population 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 No. of subjects: 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. 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. No. of sites: 54 ready for enrollment Sites location: US
Key Study Endpoints Safety Endpoints
The powered safety endpoint is a composite incidence of device- or procedure-related complication free rate at 12 months post-index implantation procedure compared to a performance goal of 75%.
1. Procedure related complications occurring through the end of 30 days following the index procedure.
2. Optimizer device-related complications occurring through the end of 1-year following the index procedure.
Observed mortality will be compared to predicted mortality for the patient group according to the Seattle Heart Failure Model (SHFM) at 1 year and 3 years post-implant.
Effectiveness Endpoints
Change in QOL, as measured by MLWHFQ, from baseline to 9 months, 2-years and 3-years following index implantation procedure.
Clinician assessment of functional class. A one – class change in functional class at 9-months, 2-years and 3-years following index implantation.
Change in LVEF and ESV at 9-months, 2-years and 3-years following index implantation.
Change in NT-proBNP at 9-months, 2-years and 3-years following index implantation.
Change in QRS duration at 9-months, 2-years and 3-years following index implantation.
Additional: An assessment of the incidence of Optimizer device-related “complications” (SADEs) and “observations” (ADEs) occurring during the 3-year period following the index procedure.
Follow-up Visits and Length of Follow-up Followed ups are scheduled:
9-month, 2-year and 3-year
3 years
Interim or Final Data Summary
Interim Results Insufficient data to provide interim results.
Actual Number of Patients Enrolled 84
Actual Number of Sites Enrolled 34
Patient Follow-up Rate N/A
Study Strengths & Weaknesses Insufficient data to provide an opinion on Strengths and Weaknesses.


OPTIMIZER System PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 09/19/2019 09/13/2019 On Time
1 year report 03/20/2020 03/11/2020 On Time
18 month report 09/18/2020 09/17/2020 On Time
2 year report 03/20/2021 04/19/2021 Overdue/Received
3 year report 03/20/2022 03/18/2022 On Time
4 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

Additional Resources

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