Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or very high risk for aortic valve surgery.
Medtronic CoreValve® System
Severe Aortic Stenosis - a heart valve disorder that narrows or obstructs the aortic valve opening. This prevents the aortic valve from opening properly, resulting in increased pressure inside the left ventricle and obstructing blood flow from the left ventricle to the aorta.
Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Device: Surgical Aortic Valve Replacement (SAVR)
Eligibility for enrollment:
- Advanced age (usually > 75 years, but not exclusively)
- Symptomatic severe aortic stenosis (NYHA Class II or greater)
- High risk for surgical aortic valve replacement
- Left ventricular ejection fraction > 20% by resting echocardiogram
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