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China S3: Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 THV in the Chinese Population

Aortic Stenosis Clinical Trial

Official title:
Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) in the Chinese Population

Clinical Trial 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.

Clinical Trial Description

Edwards SAPIEN 3 Transcatheter Heart Valve and Commander delivery system will be used for this study. A maximum of 60 patients with symptomatic severe calcific aortic stenosis requiring transcatheter aortic valve implantation (TAVI), who are considered high risk for surgical valve replacement who received a SAPIEN 3 THV. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03466918
Study type Interventional
Source Edwards Lifesciences
Contact
Status Active, not recruiting
Phase N/A
Start date May 23, 2018
Completion date September 2024
View Details
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