• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail
-

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.

Learn more...


             

ODE Lead-Cont f/u Intermediate Risk Cohort


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Study Pending
Application Number P130021 S033/ PAS001
Study Name ODE Lead-Cont f/u Intermediate Risk 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 all living subjects who were enrolled in the SURTAVI trial under the IDE (G120169). The objective of this PAS is to characterize the clinical outcomes annually through 10 years post-procedure.
Study Population Description All living subjects who were enrolled in the IDE
Sample Size All living subjects
Data Collection The key safety and effectiveness endpoints include all-cause

mortality, all stroke (disabling and non-disabling), life-threatening bleeding, acute kidney injury at stage 2 or 3, coronary artery obstruction requiring intervention, major vascular complication, valve-related dysfunction requiring repeat procedure, new permanent pacemaker implantation, prosthetic valve endocarditis, prosthetic valve thrombosis, New York Heart Association (NYHA) classification, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, and hemodynamic performance metrics by Doppler echocardiography.

Follow-up Visits and Length of Follow-up 10 years


ODE Lead-Cont f/u Intermediate Risk Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/08/2018    
one year report 07/10/2018    
18 month report 01/08/2019    
two year report 07/10/2019    
three year report 07/09/2020    


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

Related Links

-
-