Multi-CenTer Experience with the Rapid Deployment EDWARDS INTUITY Valve System FOR Aortic Valve ReplaceMent (TRANSFORM™ Trial)
Purpose of Study
The purpose of this clinical investigation is to collect human clinical data in order to demonstrate that the EDWARDS INTUITY Valve System, EDWARDS INTUITY Aortic Valve, Model 8300ACA/ACD is safe and works properly as an aortic valve replacement and that the EDWARDS INTUITY Valve System, EDWARDS INTUITY Delivery System, Model 8300DCA/DCD is safe and works properly.
Sponsor: Edwards, Inc.
Chrissy Butler, RN
Patients determined to need a biological prosthetic aortic valve replacement.
For more information, visit the ClinicalTrials.gov link.