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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-Continued f/u of premarket cohort


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General
Study Status Study Pending
Application Number P130021 S016/ PAS001
Study Name ODE Lead-Continued f/u of premarket cohort
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 Continued follow-up of premarket cohorts. The objective of this study is to characterize the cumulative clinical outcomes of all subjects through 5 years post procedure.
Study Population Description The study will consist of all living subjects who were enrolled in the ¿Low Flow Low Gradient¿ (LFLG) and ¿End-Stage Renal Disease¿ (ESRD) cohorts under the IDE.
Sample Size All living subjects.
Data Collection The safety and effectiveness endpoints include all-cause mortality or major stroke at 6 months, 12 months and annually through 5 years and the following at 30 days, 6 months, and annually through 5 years: major adverse cardiovascular and cerebrovascular event (MACCE) event rate; occurrence of individual MACCE components; major adverse events (MAE); conduction disturbance requiring permanent pacemaker implantation; change in New York Heart Association (NYHA) classification; quality of life (QoL) change as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ), SF-12, and EuroQoL; echocardiographic assessment of valve performance; aortic valve disease hospitalization; cardiovascular deaths and valve-related deaths; strokes (of any severity) and transient ischemic attacks (TIAs); and evidence of prosthetic valve dysfunction.
Follow-up Visits and Length of Follow-up 5 years


ODE Lead-Continued f/u of premarket cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 01/17/2017 01/18/2017 Overdue/Received
two year report 01/17/2018    
three year report 01/17/2019    
four year report 01/17/2020    
five year report 01/17/2021    


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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