At a glance
ClinicalIndex Comparison RecordN/ACompleted· 197 enrolled
Drug / intervention
Edwards SAPIEN XT transcatheter valve, Model 9300TFXdevice
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.
Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Patients With a Failing Aortic Bioprosthetic Valve
In Brief
A clinical study evaluating Edwards SAPIEN XT transcatheter valve, Model 9300TFX for Aortic Stenosis and Cardiomyopathy, Hypertrophic. Completed, enrolled 197 participants across 47 sites in 2 countries.
Detailed Summary
To assess the safety and effectiveness of the SAPIEN XT transcatheter heart valve in patients with a failing surgical aortic bioprosthetic valve.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Stenosis, Cardiomyopathy, Hypertrophic
CountriesCanada, United States
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2012
Primary CompletionDec 2016
First PostedJul 2017
Study CompletionOct 2020
TodayJul 2026
First PostedJul 21, 2017
Enrollment StartJun 11, 2012
Primary CompletionDec 16, 2016
Study CompletionOct 28, 2020
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 8.9 years ago
Interventions
Edwards SAPIEN XT transcatheter valve, Model 9300TFXdevice
Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems.