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Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve/ The SAPIEN 3 Study — SAPIEN3  

Aortic Valve Disease Clinical Trial

Official title:
Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve

Clinical Trial Summary

The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.

Clinical Trial Description

This is a non-randomized, prospective, multicenter safety and device success study. Two hundred fifty (250) patients are planned to be enrolled at up to 20 participating investigational centers in Europe and Canada. Patient participation will last for a minimum of 5 years. Patients will be assessed at the following intervals: baseline, hospital discharge, 30 days, 1 year and annually thereafter for a minimum of 5 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01808287
Study type Interventional
Source Edwards Lifesciences
Contact
Status Completed
Phase N/A
Start date January 2013
Completion date December 17, 2019
View Details
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