The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B

Exclusion Criteria

• •1. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
• •2. Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma \[especially if thick (\> 5 mm), protruding or ulcerated\] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta. (Transfemoral)
• •3. Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
• •4. It is known that the patient is currently enrolled in the PARTNER I Trial or was withdrawn from the PARTNER I Trial prior to endpoint analysis.
• •5. Active bacterial endocarditis within 6 months (180 days) of procedure.