5289W-12 Multi-Center Experience with the Rapid Deployment EDWARDS INTUITY Valve System for Aortic V

Multi-Center Experience with the Rapid Deployment EDWARDS INTUITY Valve System for Aortic Valve Replacement (TRANFORM Trial)

Type of Study
Heart & Vascular - Cardiac Surgery
Short Description
To assess the safety and effectiveness of the EDWARDS INTUITY Valve System in subjects with aortic stenosis or stenosis-insufficiency requiring primary replacement of the native aortic valve.
 
Status
Open
Principal Investigator
Eric Lehr, MD PhD FRCSC
Eligibility Notes
Male or female, age 18 years or older, who has aortic stenosis or stenosis-insufficiency of an aortic valve requiring a planned replacement as indicated in the preoperative evaluation, but does not demonstrate pure aortic insufficency, require emergency surgery, or have a previous aortic valve replacement or prior mitral, tricuspid or pulmonic valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ.
 
Contact Name
Deborah Tinlin, RN and Jennifer Nagel
Phone
206-215-2455
Alternate Phone
206-386-6462
Email
deborah.tinlin@swedish.org
Alternate Email
jennifer.nagel@swedish.org