PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)

Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical)

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