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REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System — REPRISE EDGE  

Aortic Valve Stenosis Clinical Trial

Official title:
REPRISE EDGE: REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System - Evaluation of Performance and Safety

Clinical Trial Summary

The objective of the REPRISE EDGE study is to confirm the acute performance and safety of the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set for transcatheter aortic valve implantation (TAVI) 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 or Lotus Introducer Set are consistent with the results of the commercially approved 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 NCT02854319
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Terminated
Phase N/A
Start date September 7, 2016
Completion date March 13, 2018
View Details
See also
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