ADVANCE Direct Aortic Study

Study Overview
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Brief Summary
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This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected.

Detailed Description
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This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected. As part of the study analysis, resource utilization together with the Quality of Life questionnaires data will provide an important input into cost effectiveness analysis.

Official Title
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CoreValve® ADVANCE Direct Aortic Study

Conditions
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Aortic Stenosis, Valvular Heart Disease

Intervention / Treatment
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* Device: CoreValve aortic valve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe symptomatic aortic valve stenosis requiring treatment Acceptable candidate for elective treatment with the Medtronic CoreValve® System according to the most recent version of the Medtronic CoreValve® Instructions For Use 21 years of age or older Patient is willing and able to comply with all protocol-specified follow-up evaluations The patient or legal representative has been informed of the nature of 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) Patient will receive the CoreValve® device via direct aortic approach TAVI - Exclusion Criteria: Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated Sepsis, including active endocarditis Recent myocardial infarction (<30 days) Left ventricular or atrial thrombus by echocardiography Uncontrolled atrial fibrillation Mitral or tricuspid valvular insufficiency (>grade II) Previous aortic valve replacement (mechanical valve or stented bioprosthetic valve) Evolutive or recent (within 6 months of implant procedure) cerebrovascular accident (CVA) or transient ischemic attack (TIA) Patients with: Vascular conditions that make insertion and endovascular access to the aortic valve impossible, or Symptomatic carotid or vertebral arterial narrowing (>70%) disease, or Thoracic aortic aneurysm in the path of delivery system Bleeding diathesis or coagulopathy Patient refuses blood transfusion Estimated life expectancy of less than 12 months unless TAVI is performed Creatine clearance <20 mL/min Active gastritis or peptic ulcer disease Pregnancy or intent to become pregnant during study follow up Patient is participating in another trial that may influence the results of this study -

Ages Eligible for Study
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Minimum Age: 21 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 aortic valve<br>Implantation of CoreValve aortic valve via direct aortic approach | Device: CoreValve aortic valve<br>* Implantation of CoreValve aortic valve via direct aortic approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause Mortality | Kaplan-Meier estimate of 30-day all-cause mortality. | 30 days post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | The combined safety endpoint is defined as a composite of: All-cause mortality All stroke Life-threatening bleeding Acute kidney injury-Stage 3 (including renal replacement therapy) Coronary artery obstruction requiring intervention Major vascular complication Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR) High degree AV block requiring permanent pacemaker implantation | 1, 6 and 12 months | 

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