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REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System

Transcatheter Aortic Valve Replacement Clinical Trial

Official title:
REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Evaluation of Safety and Performance

Clinical Trial Summary

The purpose of this study is to evaluate the safety and performance of the Lotus™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

Clinical Trial Description

The REPRISE II clinical study is a prospective, single-arm, multicenter study designed to evaluate the safety and performance of the Lotus Valve System for TAVR 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

  • Transcatheter Aortic Valve Replacement
Clinical Trial Details
NCT number NCT01627691
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Completed
Phase N/A
Start date October 8, 2012
Completion date May 13, 2019
View Details
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