Multi-Center Experience with the Rapid Deployment EDWARDS INTUITY Valve System for Aortic Valve Replacement (TRANSFORM Trial)
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.
Heart & Vascular - Cardiac Surgery
Eric Lehr, MD PhD FRCSC
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.