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REPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk Subjects — REPRISE IV  

Aortic Valve Stenosis Clinical Trial

Official title:
REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects

Clinical Trial Summary

REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects

Clinical Trial Description

To evaluate safety and effectiveness of the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Sets for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe aortic stenosis who are considered at intermediate risk for surgical valve replacement including those who have a bicuspid native valve. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03618095
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Terminated
Phase N/A
Start date January 14, 2019
Completion date March 31, 2021
View Details
See also
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