CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 17 enrolled
Drug / intervention
SAPIEN XT NovaFlex delivery systemdevice
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/NCT01419015
NCT01419015N/ACompleted
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A Clinical Trial of a 20mm Transcatheter Bioprosthetic Valve for Patients With Aortic Stenosis

Edwards Lifesciences·interventional·Posted Aug 17, 2011·Updated Aug 6, 2020

In Brief

A clinical study evaluating SAPIEN XT NovaFlex delivery system for Aortic Valve Stenosis. Completed, enrolled 17 participants across 4 sites.

Detailed Summary

A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the 20mm Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral 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
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 17, 2011
Enrollment StartJun 1, 2011
Primary CompletionJan 1, 2013
Study CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.9 years ago

Interventions

SAPIEN XT NovaFlex delivery systemdevice

Transcatheter aortic valve implantation via transfemoral approach.