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CoreValve™ Evolut R™ FORWARD Study — FORWARD  

Aortic Valve Stenosis Clinical Trial

Official title:
The Medtronic CoreValve™ Evolut R™ FORWARD Study

Clinical Trial Summary

Prospective, single arm, multi-center, observational, post market study to document the clinical and device performance outcomes of the Evolut R system used in routine hospital practice in a large patient cohort for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement.

Clinical Trial Description

The study objective is to document the clinical and device performance outcomes of the Evolut R system used in routine hospital practice in a large patient cohort for the treatment of symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement.

Prospective, single arm, multi-center, observational, post market study. In Australia and Canada it is a prospective, single arm, multi-center pre-market study.

Up to 60 centers worldwide. Geographies may include Europe, Australia, Middle East and Africa, Latin America and Canada.

Approximately 1000 implanted subjects, consented for follow-up through three years.

For each subject, data will be collected preoperatively, intra-operatively, at hospital discharge, 30 days, 1, 2 and 3 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02592369
Study type Observational
Source Medtronic Cardiovascular
Contact
Status Completed
Phase
Start date January 2016
Completion date February 6, 2020
View Details
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