Brief Title
PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
Official Title
Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical)
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 Ascendra™ transapical delivery system, and crimper accessories.
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 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.
Study Type
Interventional
Primary Outcome
Number of Deaths
Secondary Outcome
Number of Participants With a Stroke
Condition
Aortic Valve Stenosis
Intervention
SAPIEN XT™ Transapical aortic valve replacement
Study Arms / Comparison Groups
TAVR-TA
Description: Transcatheter valve replacement with transapical access
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
220
Start Date
September 2009
Completion Date
March 2016
Primary Completion Date
February 2011
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Prof. Dr. Thomas Walther, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT01238835
Organization ID
2009-06
Responsible Party
Sponsor
Study Sponsor
Edwards Lifesciences
Study Sponsor
Prof. Dr. Thomas Walther, Principal Investigator, Kerckhoff Klinik
Verification Date
October 2020