REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEm — REPRISE I  

Calcified Stenotic Native Aortic Valves Clinical Trial

Status Active, not recruiting

Clinical Trial Summary

This is a prospective, single-arm feasibility study designed to assess the acute safety and performance of the Lotus Valve System for transcatheter aortic valve replacement in symptomatic patients with calcified aortic valve stenosis and who are at high risk for surgical intervention.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Calcified Stenotic Native Aortic Valves

• NCT number: NCT01383720
• Study type: Interventional
• Source: Boston Scientific Corporation
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 2012
• Completion date: May 2017