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| General |
| Study Status |
Redesigned/Replaced Study |
Application Number /
Requirement Number |
P150048 / PAS002 |
| Date Original Protocol Accepted |
01/08/2018
|
| Date Current Protocol Accepted |
07/28/2023
|
| Study Name |
Model 11500A Prospective 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 |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
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.
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| Study Population |
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
|
| Key Study Endpoints |
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.
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| Follow-up Visits and Length of Follow-up |
Three months after TAVR ViV treatment.
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| Interim or Final Data Summary |
| Interim Results |
Number of study sites enrolled As of June 2020, there was no study site enrolled yet.
Number of subjects enrolled As of June 2020, there was no subjects enrolled yet.
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