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Performance and Safety of the Lotus™ Valve With a FLEXible Delivery System

Aortic Stenosis Clinical Trial

Official title:
REPRISE II FLEX: Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of LotuS™ ValvE With a FLEXible Delivery System - Confirmation of Performance and Safety

Clinical Trial Summary

To confirm the acute performance and safety of the Lotus™ Valve Flex System for transcatheter aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

Clinical Trial Description

This clinical study is a prospective, single-arm study designed to confirm that the acute performance and safety of the Lotus Valve Flex System for TAVR are consistent with the results of the Lotus Valve System in the REPRISE II study, when delivered and deployed in symptomatic subjects who have severe calcific aortic valve stenosis and who are at high risk for surgical aortic valve replacement (SAVR). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03043404
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Completed
Phase N/A
Start date December 3, 2013
Completion date December 10, 2018
View Details
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