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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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OSB Lead-Model 11500A Prospective PAS


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General
Study Status Study Pending
Application Number P150048 / PAS002
Date Current Protocol Accepted  
Study Name OSB Lead-Model 11500A Prospective PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, observational, non-blinded cohort study with no active current control.
The primary objective is to capture adverse event information andvalve measurement data from dysfunctional INSPIRIS RESILIA aortic valves before and after valve-in-valve (ViV) treatment.
This is a new enrollment study.
Study Population Description Adults age 18 or older at the time of the scheduled TAVR ViV treatment, determined to need routine ViV placement of an Edwards transcatheter aortic heart valve (TAVR) FDA-approved for ViV within a dysfunctional 19mm to 25mm Edwards INSPIRIS RESILIA aortic valve. Sizes 27mm and 29mm valves are not candidates for surveillance under this protocol.

Sample Size 50 subjects
Data Collection Primary effectiveness endpoints (pre-ViV, early post-ViV and 3- month post-ViV):

Quantitative measurements of the inner area of 19mm- 25mm INSPIRIS RESILIA aortic valves. Measurements will be taken prior to ViV placement (“pre-ViV”), after placement at discharge or Day 7 post ViV whichever comes first (“early post-ViV”) and 3-months following the ViV procedure (“3- months post-ViV”).

Primary safety endpoints (up to 30 days):

The composite endpoint for transcatheter aortic valve implantation evaluated up to 30 days. The composite endpoint consists of all-cause mortality, all stroke (disabling and non- disabling), life-threatening bleeding, acute kidney injury – stage 2 or 3 (including renal replacement therapy), coronary artery obstruction requiringintervention, majorvascularcomplication, and valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR).

Secondary safety endpoints (through 3 months): Myocardial Infraction, conduction disturbance requiring pacemaker, transient ischemic attack, hemorrhagic stroke,

device fracture, new requirement for dialysis, unplanned other cardiac surgery or intervention (excluding AVR or PCI), PCI, non- valve related readmission, minor vascular complication, major bleeding event, endocarditis, conduction disturbance requiring ICD, ischemic stroke, undetermined stroke, device thrombosis, aortic valve re-intervention, unplanned vascular surgery or

intervention (for bleeding or access site complication), valve related readmission, major vascular complication, transapical related event, life threatening bleeding.





Follow-up Visits and Length of Follow-up Three months after TAVR ViV treatment.


OSB Lead-Model 11500A Prospective PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/28/2017 12/22/2017 On Time
one year report 06/29/2018 06/21/2018 On Time
18 month report 12/28/2018    
two year report 06/29/2019    
three year report 06/28/2020    
four year report 06/28/2021    


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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