At a glance
ClinicalIndex Comparison RecordN/ACompleted· 560 enrolled
Drug / intervention
TAVR Implantation with SAPIEN XT +1 moredevice
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.
The PARTNER II Trial "Placement of AoRTic TraNscathetER" Valves Trial" (US) [PII B] for Inoperable Patients
In Brief
A clinical study evaluating TAVR Implantation with SAPIEN XT and TAVR Implantation with SAPIEN for Severe and 2 related conditions. Completed, enrolled 560 participants across 53 sites.
Detailed Summary
The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere, Symptomatic, Calcific Aortic Stenosis
CountriesUnited States
CollaboratorsAmerican College of Cardiology
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2011
Primary CompletionMay 2013
First PostedJul 2014
Study CompletionMay 2017
TodayJul 2026
First PostedJul 9, 2014
Enrollment StartMar 9, 2011
Primary CompletionMay 1, 2013
Study CompletionMay 30, 2017
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.0 years ago
Interventions
TAVR Implantation with SAPIEN XTdevice
Inoperable operable patients requiring the transcatheter aortic heart valve replacement
TAVR Implantation with SAPIENdevice
Inoperable operable patients requiring the transcatheter aortic heart valve replacement