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Lay Description

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

  • Nervous System
IRB Number
20110120HU
NCT Number
ct.gov registration not required
Open to Enrollment
Yes

Eligibility

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

Inclusion Criteria

Exclusion Criteria

Study Design

Arm Groups

Study Contact


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

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