Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis

Abbott BE TAVI Early Feasibility Study: Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis

The purpose of this study is to evaluate the safety and functionality of Abbott's BE TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis.

The EFS will evaluate the safety and functionality of Abbott's BE TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis.

Inclusion Criteria:

• Subject is at least 18 years of age
• Subject is able and willing to return for required follow-up visits and assessments
• Degenerative severe aortic valve stenosis of the native aortic valve with echo-derived criteria

Exclusion Criteria:

• Pregnant or nursing subjects
• Life expectancy for a condition other than aortic stenosis is less than 2 years
• Presence of other anatomic or comorbid conditions
• Incapacitated individuals
• Evidence of an acute myocardial infarction
• Untreated clinically significant coronary artery disease requiring revascularization
• Liver failure
• Severe mitral regurgitation or severe mitral stenosis
• etc.