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Multi-Center Experience with the Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement (TRANSFORM TRIAL)
A study for patients who require aortic valve replacement using an investigational device called Edwards Intuity Valve System
| Sponsor: | Edwards Lifesciences |
| Enrolling: | Male and Female Patients |
| IRB Number: | AAAO2706 |
| U.S. Govt. ID: | NCT01700439 |
| Contact: | Michael Borger: 212-305-4980 / mb3851@columbia.edu |
Additional Study Information:
The purpose of this clinical investigation is to collect human clinical data in order to demonstrate thatthe EDWARDS INTUITY Valve System, EDWARDS INTUITY Aortic Valve, Model 8300ACA/ACD issafe and works properly as an aortic valve replacement and that the EDWARDS INTUITY ValveSystem, EDWARDS INTUITY Delivery System, Model 8300DCA/DCD is safe and works properly. Thedelivery system is a part that the doctor uses to put the EDWARDS INTUITY Aortic Valve in the rightplace. This part does not stay in your body after the surgery.
This study is closed
