CoreValve Advance International Post Market Study

Study Overview
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Brief Summary
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The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System in a Real-World patient population.

Detailed Description
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The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System for percutaneous aortic valve implantation in a Real-World patient population with severe aortic valve stenosis. Data collected in this study will provide additional information on the understanding of the safety and device performance and how to best treat elderly patients with severe aortic valve stenosis. In addition, health economic data will be collected to understand the improvement of quality of life and the cost effectiveness of the therapy.

Official Title
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CoreValve Advance International Post Market Study: Evaluation of the Medtronic CoreValve System in a Real-World Patient Population.

Conditions
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Severe Aortic Stenosis

Intervention / Treatment
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* Device: Medtronic CoreValve System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with severe aortic valve stenosis requiring treatment Patient is an acceptable candidate for elective treatment with the Medtronic CoreValve System and in conformity with the local regulatory and medico economical context Patient is above the minimum age as required by local regulations to be participating in a clinical study 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) Exclusion Criteria: Currently participating in another trial High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) Pregnancy

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 |
| --- | --- |
| severe aortic valve stenosis<br>elderly patients with severe aortic valve stenosis requiring treatment | Device: Medtronic CoreValve System<br>* Transcatheter Aortic Valve Implantation of the Medtronic CoreValve System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac & Cerebrovascular Events (MACCE) | MACCE is defined as a composite of: All cause mortality Myocardial Infarction (Q-wave and non-Q-wave) Emergent cardiac surgery or percutaneous re-intervention Stroke The Kaplan-Meier survival analysis was used to derive the freedom from MACCE at 30 days. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Device Success | Device Success is defined as a composite of: Successful device delivery; Stable device placement; Intact retrieval of delivery catheter; Successful device function as assessed immediately post-procedure by angiography including non-compromised flow in coronary arteries (without obstruction) device position (no migration) and a mean gradient as determined invasively of <15mmHg and ≤ 2 aortic regurgitation | up to 24 hours | 
| Percentage of Participants With Procedural Success | Procedural success, defined as device success with absence of in-hospital MACCE | up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advance, Medtronic CoreValve System, International, Interventional, Post Market Study