The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System in a "Real-World" patient population.
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.
Study Type
OBSERVATIONAL
Enrollment
1,015
Transcatheter Aortic Valve Implantation of the Medtronic CoreValve System
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.
Time frame: 30 days
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
Time frame: up to 24 hours
Percentage of Participants With Procedural Success
Procedural success, defined as device success with absence of in-hospital MACCE
Time frame: up to 30 days
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