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Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve — TRANSFORM™  

Aortic Valve Stenosis Clinical Trial

Official title:
Multi-CenTer Experience With the Rapid Deployment EDWARDS INTUITY Valve System FOR Aortic Valve ReplaceMent

Clinical Trial Summary

The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.

Clinical Trial Description

This is a prospective, non-randomized, multi-center trial. Up to 950 subjects will be enrolled at up to 35 centers in the US. After replacement of their aortic heart valve with the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the following intervals: discharge, 3 months, 1 year, and annually thereafter for a minimum of five years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01700439
Study type Interventional
Source Edwards Lifesciences
Contact
Status Completed
Phase N/A
Start date September 26, 2012
Completion date May 26, 2021
View Details
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