The Partner II
This trial determines the safety and effectiveness of the Edwards SAPIEN XT and the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.
The Partner III
This trial determines the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement (AVR).
This trial evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis patient who require replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic valve.
On-X® Valve Using Low Dose Anticoagulation
This trial compares patients with the On-X valve on low dose anticoagulation (test group) to control groups of On-X valves receiving standard Coumadin/aspirin therapy, and also to FDA objective performance criteria (OPC) for heart valve replacement.