Early System Experience With the Abbott Balloon-expandable TAVI System: First-In-Human Study

EASE Study: Early System Experience With the Abbott Balloon-expandable TAVI System: First-In-Human Study

Early System Experience with the Abbott Balloon-expandable TAVI System

The Early System Experience with the Abbott's balloon-expandable TAVI System first-in-human study ('EASE study') will evaluate preliminary clinical evidence on the safety and feasibility of the Abbott's balloon-expandable TAVI system for the treatment of patients with symptomatic severe aortic valve stenosis.

Inclusion Criteria:

• Increased surgical risk
• Appropriate anatomy
• At least 18 years of age
• Willing to return for follow-up assessments

Exclusion Criteria:

• Pregnant or nursing subjects
• Anatomic or comorbid conditions
• Evidence of acute myocardial infarction
• Inoperable/ineligible for surgery
• Renal disease requiring chronic dialysis