CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 67 enrolled
Drug / intervention
SAPIEN XT THV with the 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/NCT03314857
NCT03314857N/ACompleted
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Safety and Effectiveness of Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve in the Chinese Population

Edwards Lifesciences·interventional·Posted Oct 19, 2017·Updated Sep 5, 2023

In Brief

A clinical study evaluating SAPIEN XT THV with the NovaFlex+ delivery system for Aortic Stenosis and 2 related conditions. Completed, enrolled 67 participants across 3 sites.

Detailed Summary

To evaluate the safety and effectiveness of the SAPIEN XT (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are considered at high risk for surgical valve replacement.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Stenosis, Symptomatic Aortic Stenosis, Aortic Regurgitation
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 19, 2017
Enrollment StartSep 18, 2017
Primary CompletionJul 6, 2018
Study CompletionJun 15, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 8.7 years ago

Interventions

SAPIEN XT THV with the NovaFlex+ delivery systemdevice

Edwards SAPIEN XT™ Transcatheter Heart Valve along with NovaFlex+ delivery system