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Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement (REPRISE Japan)

Aortic Stenosis Clinical Trial

Official title:
REPRISE Japan: Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Clinical Evaluation in Japan

Clinical Trial Summary

The objective of this study is to confirm the safety and effectiveness of the Lotus™ Valve System in the Japanese medical environment for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at high or extreme risk for surgical valve replacement.

Clinical Trial Description

A prospective, multicenter trial designed to confirm that the safety and effectiveness of the Lotus Valve System in the Japanese medical environment are consistent with the REPRISE III results for TAVR in symptomatic subjects who have calcific, severe native aortic stenosis and who are at extreme or high risk for surgical valve replacement. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02491255
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Completed
Phase N/A
Start date June 22, 2015
Completion date September 13, 2021
View Details
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