CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 64 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.

Search/NCT01113983
NCT01113983N/ACompleted
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A Clinical Trial of a Transcatheter Bioprosthetic Valve for Patients With Aortic Stenosis

Edwards Lifesciences·interventional·Posted Apr 30, 2010·Updated May 1, 2020

In Brief

A clinical study evaluating Transcatheter aortic valve implantation for Aortic Valve Stenosis. Completed, enrolled 64 participants across 3 sites.

Detailed Summary

A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, Ascendra2™ transapical delivery system and crimper accessories. The trial includes a premarket pivotal cohort to evaluate the system performance as well as a post market clinical follow-up phase involving long term follow-up of all patients to evaluate the safety of investigational devices up to 5 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Valve Stenosis
CountriesJapan
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 30, 2010
Enrollment StartApr 1, 2010
Primary CompletionOct 1, 2011
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.2 years ago

Interventions

Transcatheter aortic valve implantationdevice

Transcatheter aortic valve implantation via transapical and transfemoral approach