Purpose

The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.

Category

IRB Number
20110120HU
NCT Number
-
Open to Enrollment
Yes
Sponsor
Edwards Lifesciences -



Study Contact

Local Recruitment Point of Contact
Jean Hardies
210-567-8181
hardiesl@uthscsa.edu

Local Recruitment Point of Contact
Mary Woolsey
(210) 567-8049
woolseym@uthscsa.edu

Principal Investigator
Geoffrey Clarke

Regulatory Point of Contact
Mary Woolsey
(210) 567-8049
woolseym@uthscsa.edu



Eligibility

Eligible Ages
Over 19 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Arm Groups