At a glance
ClinicalIndex Comparison RecordN/ACompleted· 199 enrolled
Drug / intervention
TAVR Implantation of the Transcatheter Aortic Valve Prosthesisdevice
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.
A Multicentre, Non-Randomised Controlled Study of the Safety, Performance, Quality of Life and Cost Effectiveness Outcomes of the Edwards SAPIEN XT™ Transcatheter Heart Valve in an Australian Population
In Brief
A clinical study evaluating TAVR Implantation of the Transcatheter Aortic Valve Prosthesis for Severe, Symptomatic Aortic Stenosis. Completed, enrolled 199 participants across 11 sites.
Detailed Summary
The objective of the study is to observe the safety, efficacy and cost effectiveness of the Edwards SAPIEN XT valve for the treatment of severe calcific degenerative aortic stenosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere, Symptomatic Aortic Stenosis
CountriesAustralia
CollaboratorsPacific Clinical Research Group
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2012
First PostedAug 2012
Primary CompletionFeb 2016
Study CompletionAug 2018
TodayJul 2026
First PostedAug 30, 2012
Enrollment StartApr 1, 2012
Primary CompletionFeb 1, 2016
Study CompletionAug 8, 2018
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 13.8 years ago
Interventions
TAVR Implantation of the Transcatheter Aortic Valve Prosthesisdevice
Operable subjects