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TranScatheter Aortic Valve RepLacement System US Feasibility Trial — SALUS  

Aortic Valve Stenosis Clinical Trial

Official title:
The Direct Flow Medical TranScatheter Aortic Valve RepLacement System US Feasibility Trial

Clinical Trial Summary

A study to assess the safety and effectiveness of the Direct Flow Medical aortic valve system. This is for people with severe aortic stenosis who are not well enough to undergo a surgical repair. The delivery of this device is done via the femoral artery.

Clinical Trial Description

The Direct Flow Medical Transcatheter Aortic Valve System is indicated for symptomatic patients who require replacement of their native aortic valve and have a predicted operative mortality or serious morbidity risk of equal or greater 50% at 30 days with surgical aortic valve replacement or are deemed unsuitable for surgery. ;

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 NCT01932099
Study type Interventional
Source Direct Flow Medical, Inc.
Contact
Status Active, not recruiting
Phase Phase 2
Start date August 2013
Completion date December 2018
View Details
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