At a glance
ClinicalIndex Comparison RecordN/ACompleted· 222 enrolled
Drug / intervention
Transcatheter Aortic Valve Implantationdevice
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.
Assessment Of The St. Jude Medical Portico™ Transcatheter Aortic Valve Implant (TAVI) And The SJM TAVI Transfemoral Delivery System (Portico TF EU)
In Brief
A clinical study evaluating Transcatheter Aortic Valve Implantation for Symptomatic Aortic Stenosis. Completed, enrolled 222 participants across 14 sites in 5 countries.
Detailed Summary
The purpose of this study is to assess the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and the SJM TAVI Transfemoral Transcatheter delivery system in subjects with severe symptomatic aortic stenosis (AS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSymptomatic Aortic Stenosis
CountriesAustralia, Denmark, Germany, Netherlands, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2011
First PostedDec 2011
Primary CompletionOct 2015
Study CompletionSep 2016
TodayJul 2026
First PostedDec 15, 2011
Enrollment StartDec 1, 2011
Primary CompletionOct 1, 2015
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 14.5 years ago
Interventions
Transcatheter Aortic Valve Implantationdevice
Placement of the SJM Portico aortic valve with a transfemoral delivery system