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REPRISE Next Generation Delivery System — NGDS  

Aortic Stenosis Clinical Trial

Official title:
REPRISE NGDS: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of LotuS™ ValvE With the Next Generation Delivery System

Clinical Trial Summary

To confirm the acute performance and safety of the Lotus™ Valve with the Next Generation Delivery 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 demonstrate that the acute performance and safety of the LOTUS Edge Valve System when used with the iSleeve Introducer Set or current Lotus Introducer Set are consistent with the results of the Lotus Valve System used 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 NCT02329496
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Completed
Phase N/A
Start date December 3, 2014
Completion date October 19, 2017
View Details
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