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Freedom SOLO Stentless Heart Valve Study — SOLO  

Aortic Stenosis Clinical Trial

Official title:
Clinical Investigation of the Freedom SOLO Stentless Heart Valve in North America

Clinical Trial Summary

The purpose of this clinical investigation is to demonstrate the safety and effectiveness of the Freedom SOLO heart valve.

Clinical Trial Description

The SOLO clinical investigation is a prospective, non-randomized, multicenter trial of the SOLO Freedom heart valve implanted in patients requiring aortic valve replacement. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01115907
Study type Interventional
Source Sorin Group USA, Inc.
Contact
Status Completed
Phase Phase 3
Start date December 2010
Completion date October 2014
View Details
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