REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects
Brief description of study
The purpose of this research study is to evaluate safety and effectiveness of the LOTUS EdgeTM Valve System when used with the LotusTM or iSleeveTM 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.
Clinical Study Identifier: s19-00061
ClinicalTrials.gov Identifier: NCT03618095
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