At a glance
ClinicalIndex Comparison RecordN/ACompleted· 220 enrolled
Drug / intervention
SAPIEN XT™ Transapical aortic valve replacementdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical)
In Brief
A clinical study evaluating SAPIEN XT™ Transapical aortic valve replacement for Aortic Valve Stenosis. Completed, enrolled 220 participants across 20 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Valve Stenosis
CountriesAustria, France, Germany, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2009
First PostedNov 2010
Primary CompletionFeb 2011
Study CompletionMar 2016
TodayJul 2026
First PostedNov 11, 2010
Enrollment StartSep 1, 2009
Primary CompletionFeb 1, 2011
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 15.6 years ago
Interventions
SAPIEN XT™ Transapical aortic valve replacementdevice
Transcatheter aortic valve implantation via the transapical approach