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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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ENDURANCE PAS


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General
Study Status Progress Inadequate
Application Number P100047 S090/ PAS002
Date Current Protocol Accepted  
Study Name ENDURANCE PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objective of the study is to estimate patient survival free of death, disabling stroke, or device malfunction or failure requiring exchange, explantation or urgent transplantation following HeartWare Ventricular Assist Device (HVAD) implantation for destination therapy (DT).

This post-approval study (PAS) is a prospective, observational, multi-site study conducted through Medtronic’s Product Surveillance Registry (PSR).
Study Population Description Patients using the HVAD system as destination therapy.
Sample Size The PAS cohort will be comprised of 300 newly enrolled patients. This sample size will estimate the primary endpoint rate at 24 months post-original implant within 6.0%. The following assumptions were used:

- Two-sided 95% confidence intervals will be computed

- Goal is to estimate the primary objective survival rate at 2 years

- Survival rate at 24 months is 59.2%, which is based on the Endurance Supplemental HeartWare success rate using data through March 27, 2017 (data pull May 30, 2017).

- Attrition will be 10% from implant to 24 months, primarily consisting of transplants

Approximately 50 sites will participate in the PAS.
Data Collection The primary endpoint/objective is survival free of disabling stroke or device malfunction requiring exchange, explant, or urgent transplant.

Secondary endpoints:

- Observed early stroke rate (stroke occurring =2 years post-implant), and stroke risk factors.

- Late stroke rate (stroke occurring >2 years post-implant) and to evaluate risk factors for late stroke.

- Stroke severity for all subjects who experience a stroke on device while in this study. Stroke severity will be assessed through modified Rankin Scale (mRS) scoring.

Additional endpoints:

Effectiveness of Invasive Blood Pressure Monitoring (IBPM), a summary of neurologic dysfunction events (ischemic cerebrovascular accidents, hemorrhagic cerebrovascular accidents, and transient ischemic attacks), overall survival on device, INTERMACS adverse event rates, quality of life measures (measured by EuroQol EQ-5D-DL and Kansas City Cardiomyopathy Questionnaire), and functional status (measured by the 6-minute walk test).
Follow-up Visits and Length of Follow-up Subjects will be followed through five years post-implant


ENDURANCE PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 03/28/2018 04/25/2018 Overdue/Received
one year report 09/27/2018 09/12/2018 On Time
18 month report 03/28/2019 03/28/2019 On Time
two year report 09/27/2019    
30 month report 03/27/2020    
three year report 09/26/2020    
four year report 09/26/2021    


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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