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|
| General |
| 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
|
| Device Name |
EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)
|
| 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.
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| Sample Size |
50 subjects
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| 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
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| Follow-up Visits and Length of Follow-up |
one month after TAVR ViV treatment
|
