CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 58 enrolled
Drug / intervention
SAPIEN 3 THV with the Commander 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/NCT03466918
NCT03466918N/ACompleted
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Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) in the Chinese Population

Edwards Lifesciences·interventional·Posted Mar 15, 2018·Updated Sep 10, 2025

In Brief

A clinical study evaluating SAPIEN 3 THV with the Commander delivery system for Aortic Stenosis and 2 related conditions. Completed, enrolled 58 participants across 4 sites.

Detailed Summary

To evaluate the safety and effectiveness of the SAPIEN 3 (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 PostedMar 15, 2018
Enrollment StartMay 23, 2018
Primary CompletionJul 3, 2019
Study CompletionJun 19, 2024
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.3 years ago

Interventions

SAPIEN 3 THV with the Commander delivery systemdevice

Edwards SAPIEN 3 Transcatheter Heart Valve is implanted using the Commander delivery system