CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis.

Study Overview
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Brief Summary
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This observational study is intended to collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI).

Detailed Description
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To collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for TAVI in patients with failing surgical aortic bioprosthesis who are at high risk for redo surgery.

Official Title
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Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. A Prospective, Observational Post-market Study.

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: CoreValve Transcatheter Valve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is > 18 years old Patient has a symptomatic degeneration of aortic bioprosthesis Acceptable candidate for elective treatment with the Medtronic CoreValveTM System (according to the most recent version of the Medtronic CoreValveTM Instructions For Use) and in conformity with the local regulatory and reimbursement context Logistical Euroscore > 20% or STS > 10% or presence of comorbidities responsible of contra-indication(s) for redo surgery as assessed by at least one cardiac surgeon or patients in whom heart team has assessed the redo surgery at high risk The patient or legal representative has been informed of the nature of the procedure and the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form (Patient Informed Consent Form) The patient is willing and able to comply with requirements of the study, including the 24 months follow-up Patient will receive the CoreValveTM device in a degenerated surgical bioprosthesis Exclusion Criteria: Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated Patient in whom heart team considers that risk of TAVI is too high with a particular attention for the risk of coronary occlusion Patient with prior endocarditis on failed bioprosthesis Patient has other medical illness associated with a limited life expectancy (i.e., less than 1 year) Patient with LVEF <20%, cardiogenic shock, or hemodynamic compromise requiring pressors or inotropes or mechanical support devices Patient with severe mitral disease associated with severe pulmonary hypertension Acute coronary syndrome less than 7 days before intervention Currently participating in another investigational drug or device study. Patient with significant paravalvular regurgitation Patient in whom internal diameter prosthesis is equal to 17 mm

Ages Eligible for Study
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Minimum Age: 18 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CoreValve Transcatheter Valve<br>Medtronic CoreValve SystemTM is designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failing valve. The support frame is manufactured by Nitinol, which has multi-level, self-expanding properties and is radiopaque. The bioprosthesis is manufactured by suturing valve leaflets and a skirt from a single layer of porcine pericardium into a tri-leaflet configuration. The bioprosthesis is processed with alpha-amino oleic acid (AOA™), which is a compound derived from oleic acid, a naturally occurring long-chain fatty acid. AOA™ is an antimineralization treatment shown to reduce both early and late valvular calcification. | Device: CoreValve Transcatheter Valve<br>* Patients should be accepted for TAVI by a multidisciplinary team. The procedure should use the Medtronic CoreValve SystemTM and point of enrolment is the day of the procedure. The choice of prosthesis size and access route (transfemoral, subclavian or direct aortic access) is to be left to the discretion of the operating team. Equally the intraprocedural details (anaesthetic, imaging etc.) will proceed as per usual practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular death |  | 30 days post-index procedure | 
| Lack of significant aortic stenosis or insufficiency |  | 1 year Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety composite endpoint based on VARC-II endpoint definitions |  | At 30 days and during follow-up visits | 
| Peri-procedural myocardial infarction, major and minor access site complications, major bleeding, stroke, acute kidney injury stage III, new pacemaker implantation, and post-implantation aortic gradient |  | At 30 days and during follow-up visits |