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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Model 11500A Valve-in-Valve PAS

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Study Status Study Pending
Application Number /
Requirement Number
P150048 / PAS003
Date Original Protocol Accepted 07/28/2023
Date Current Protocol Accepted 07/28/2023
Study Name Model 11500A Valve-in-Valve PAS
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is a single-arm observational study which includes both prospective and retrospective data.
Study Population Adults age 18 or older at the time of the 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.
Sample Size 50 subjects
Key Study Endpoints Primary effectiveness endpoints (pre-ViV and post-ViV):
Quantitative measurements of the inner area of 19mm- 25mm INSPIRIS RESILIA aortic valves post-ViV compared to baseline. Measurements will be taken prior to ViV placement (“pre-ViV” or baseline) and after placement at Day 30 or later (post-ViV).
Primary safety endpoints (up to 30 days):
A composite of all-cause mortality, all stroke (disabling and non-disabling), life-threatening bleeding, new requirement for dialysis, coronary artery compression or obstruction, major vascular complication, and valve-related dysfunction requiring reintervention, through 30 days following the transcatheter aortic valve implantation.
An incidence of valve malpositioning including all instances of ViV-TAVR migration, embolization, and valve recapture or retrieval up to 30 days post-ViV.
Additional outcomes (through 1 month):
In alignment with the TVT registry data collection, reportable adverse events, readmissions, interventions, and surgical procedures including the following will be assessed up to 30 days:
• Myocardial Infraction • Endocarditis • Conduction Disturbance requiring Pacemaker • Atrial Fibrillation • Aortic Dissection • Conduction Disturbance requiring ICD • Cardiac Arrest • Annular Dissection • Perforation with or without Tamponade • Transient Ischemic Attack • Ischemic Stroke • Hemorrhagic Stroke • Undetermined stroke • Device Fracture • Device Thrombosis • New Requirement for Dialysis • Aortic Valve Re-intervention • Unplanned Other Cardiac Surgery or Intervention (excluding AVR or PCI) • Unplanned Vascular Surgery or Intervention (for Bleeding or Access Site Complication) • PCI • Valve Related Readmission • Non-Valve Related Readmission • Major Vascular Complication • Minor Vascular Complication • Transapical Related Event • Major Bleeding Event • Bleeding at Access Site • Retroperitoneal Bleeding • GU Bleed • Device Embolization LV • Device Recapture or Retrieval • Life Threatening Bleeding • Hematoma at Access Site • GI Bleed • Other Bleed • Device Embolization Aorta • Coronary Compression or Obstruction • Other Device Related Event
Follow-up Visits and Length of Follow-up one month after TAVR ViV treatment

Model 11500A Valve-in-Valve PAS Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 12/28/2028    
1 year report 06/28/2029    
18 month report 12/28/2029    
2 year report 06/28/2030    
final report 06/28/2031    

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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