PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating
 the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next
 generation Ascendra™ transapical delivery system, and crimper accessories.
Purpose: The purpose of this trial is to evaluate the acute safety and effectiveness of the
 SAPIEN XT™ study valve and next generation Ascendra™ delivery components.

 Follow-up Intervals: Subject data collection will include clinical information at baseline
 and during the index procedure. Subjects will undergo clinical follow-up at discharge, 30
 days, 6 month annually for 5 years.
Inclusion:

 1. EuroSCORE of ≥ 15 %

 2. Severe senile degenerative aortic valve stenosis

 3. Symptomatic aortic valve stenosis

 4. Informed consent

 5. Compliance

 Exclusion:

 1. Logistic Euroscore > 40 %

 2. Evidence of an acute myocardial infarction

 3. Congenital unicuspid or congenital bicuspid valve/ non-calcified

 4. Mixed aortic valve disease