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FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System

Aortic Valve Stenosis Clinical Trial

Official title:
FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System

Clinical Trial Summary

Prospective, single-arm, multi-center, interventional post-market study. After signing informed consent, eligible subjects will be implanted with the CE marked Evolut™ PRO system. The investigation purpose is to evaluate the acute and long term clinical performance and safety of Evolut™ PRO in a routine hospital setting in patients with symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement within the approved intended use in local geography.

Clinical Trial Description

Approximately 600 subjects implanted with the Evolut™ PRO at up to 40 sites in Europe. Other regions may be added depending on the regulatory status of the device. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03417011
Study type Observational
Source Medtronic Cardiovascular
Contact
Status Completed
Phase
Start date February 26, 2018
Completion date February 26, 2024
View Details
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