RESILIENCE Trial: Evaluation of the Durability of Aortic Bioprostheses/Valves With RESILIA Tissue in Subjects Under 65

Study Overview
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Brief Summary
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The objective of this observational trial is to determine time to valve failure due to valve deterioration requiring re-intervention and collect/investigate early potential predictors of valve durability (e.g., calcification and hemodynamic deterioration) in RESILIA tissue valves.

Detailed Description
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Multicenter, prospective, non-randomized, single-arm, observational trial. Subjects will be evaluated at 5, 7, 9, and 11 years post-implant. Up to two hundred fifty (250) total subjects at up to fifteen (15) investigational sites will be enrolled.

Official Title
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Prospective Non-randomized Single Arm Multi-center Evaluation of the Durability of Aortic Bioprostheses/Valves With RESILIA Tissue in Subjects Under 65 (RESILIENCE Trial)

Conditions
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Aortic Valve Replacement

Intervention / Treatment
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* Diagnostic Test: Subjects previously implanted with a RESILIA aortic tissue valve.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Subject currently has an Edwards pericardial aortic bioprosthesis with RESILIA tissue Provides voluntary written informed consent prior to the first trial related procedure Subject agrees to attend follow-up assessments as specified in the protocol Exclusion Criteria: Age 65 years or older at time of aortic valve replacement The Subject is pregnant or planning to become pregnant at the time of screening Re-intervention required on the bioprosthetic aortic valve prior to screening Active endocarditis or history of endocarditis on bioprosthetic aortic valve Estimated life expectancy <24 months Subjects with history of or current renal failure requiring dialysis Altered mineral metabolism (hyperparathyroidism, parathyroid tumors) Has prior organ transplant or is currently an organ transplant candidate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Subjects previously implanted with a RESILIA aortic tissue valve.|Subjects to undergo multi-slice computed tomography and echocardiogram to assess predictors of valve durability in previously implanted Edwards aortic valves with RESILIA tissue.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to bioprosthetic valve failure due to valve deterioration | Time to bioprosthetic valve failure due to valve deterioration is defined as subject requiring valve re-intervention (redo surgery, valve-in-valve) or confirmed study valve-related death. | 11 years post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of early possible predictors of valve failure including leaflet calcification and morphological/hemodynamic valve deterioration | Quantification of valve leaflet calcification via core lab evaluated multi-slice computed tomography (MSCT) Hemodynamic performance of the valve and evaluation for possible morphological/hemodynamic valve deterioration confirmed by core lab evaluation of echo-cardiography | 5, 7, 9, and 11 years post-implant |