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

Aortic Valve Stenosis Clinical Trial

Official title:
Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical)

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01238835
Study type Interventional
Source Edwards Lifesciences
Contact
Status Completed
Phase N/A
Start date September 2009
Completion date March 2016
View Details
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