Status:
COMPLETED
PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
Lead Sponsor:
Edwards Lifesciences
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 Ascendr...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Inclusion:
- EuroSCORE of ≥ 15 %
- Severe senile degenerative aortic valve stenosis
- Symptomatic aortic valve stenosis
- Informed consent
- Compliance
- Exclusion:
- Logistic Euroscore \> 40 %
- Evidence of an acute myocardial infarction
- Congenital unicuspid or congenital bicuspid valve/ non-calcified
- Mixed aortic valve disease
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT01238835
Start Date
September 1 2009
End Date
March 1 2016
Last Update
November 2 2020
Active Locations (20)
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1
Medizinische Universitat Wien Univ.Klinik f.Chirurgie
Vienna, Austria, 1019
2
Hôspital Bichat
Paris, France, 75018
3
Herz-Und Gefasszentrum Bad Bevensen
Bad Bevensen, Germany, 29549
4
Kerckhoff-Klinik
Bad Nauheim, Germany, 61231