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CENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve

Aortic Valve Disease Clinical Trial

Official title:
Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve

Clinical Trial Summary

The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in symptomatic adult patients with severe aortic stenosis.

Clinical Trial Description

This is a non-randomized, prospective, multi-center safety and device success study. Up to two hundred (200) patients are planned to be implanted at up to 35 participating investigational centers in Europe, Australia and New Zealand. Patient participation will last for a minimum of 5 years. Patients will be assessed at the following intervals: baseline, discharge, 30 days, 6 months, 1 year and annually thereafter through 5 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02458560
Study type Interventional
Source Edwards Lifesciences
Contact
Status Completed
Phase N/A
Start date March 2015
Completion date August 13, 2021
View Details
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