Inspiris Resilia Durability Registry

Study Overview
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Brief Summary
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Prospective, open-label, multicenter, European registry with a follow-up of 5 years to assess the clinical outcomes of patients younger than 60 years who undergo surgical AVR with the INSPIRIS RESILIA Aortic Valve™.

Detailed Description
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The INSPIRIS RESILIA Aortic Valve™ is a stented tri-leaflet valve comprised of bovine pericardial tissue. The tissue is created by treating bovine pericardial tissue with Edwards Integrity Preservation. It incorporates a stable capping anticalcification process, which blocks residual aldehyde groups known to bind with calcium. Tissue preservation with glycerol allows the valve to be stored without a traditional liquid-based solution, such as glutaraldehyde. Therefore, valve is stored under dry packaging conditions and consequently does not require rinsing prior to implantation. The novel tissue preservation technology significantly improves hemodynamic and anticalcification properties compared with the standard Perimount valve in an ovine model. In this registry, data is collected over a period of 5 years to demonstrate these properties in a clinical real-life setting. Clinical outcomes, hemodynamic as well as safety parameters and quality of life data are documented into e-CRF at baseline, surgery, pre-discharge, 3-6 months and annually up to year 5. The required sample size was calculated using the online calculator at http://www.surveysystem.com/sscalc.htm. It was estimated, from COMMENCE Trial dataset that freedom from time-related valve safety events at 1 year (composite endpoint according to VARC-2) is around 0.915. The following table illustrates 95% CIs at different levels of risk: Sample Size Observed freedom from event 95%CI 400 0.900 ± 0.0294 400 0.910 ± 0.0280 400 0.915 ± 0.0214 400 0.920 ± 0.0266 400 0.930 ± 0.0250 20% of registry sites will be monitored with 100% source data verification

Official Title
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Clinical Outcomes of Patients Under the Age of Sixty Undergoing INSPIRIS RESILIA Aortic Valve Replacement

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: AVR with or without CABG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 60 years inclusive Subject requiring a planned replacement of their native aortic valve as indicated in a preoperative evaluation Subject is scheduled to undergo planned aortic valve replacement with or without concomitant root replacement and/or coronary bypass surgery Subject is scheduled to attend yearly follow-up visits at the registry center up to 5 years follow-up Subject provides written informed consent prior to the procedure Exclusion Criteria: Active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery Previous aortic valve replacement Valve implantation is not possible in accordance with the device IFU Subject has a life expectancy ≤ 12 months for any reason Intraoperative Exclusion criteria: 1. Valve implantation is not possible in accordance with the device IFU

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- |
|Device: AVR with or without CABG|Surgical aortic valve implantation with INSPIRIS RESILIA Aortic Valve™|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-related valve safety | Composite endpoint according to VARC-2 depicted as freedom from event: SVD (structural valve deterioration) Valve-related dysfunction Requirement of repeat procedure Prosthetic valve endocarditis Prosthetic valve thrombosis Thromboembolic events (e.g. stroke) Valve-related VARC bleeding | Year 1 | 
| Freedom from severe SVD (structural valve deterioration) | Freedom from stage 3 SVD including stenosis and regurgitation determined by echocardiography | Year 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Surgical valve