CarboMedics Top Hat vs St. Jude Medical Regent Valve Comparing Sizing and Hemodynamics

A Randomized Study to Compare Sizing, Implant Techniques, & Hemodynamic Performance Between the CarboMedics Supra-annular Top Hat Valve and the St. Jude Medical Regent Valve in the Aortic Position.

The purpose of this study is to compare the sizing and implant techniques between the CarboMedics Top Hat supra-annular valve and the St. Jude Medical Regent valve.

Inclusion Criteria:

• Patients who are indicated for implant with a mechanical valve prosthesis in the aortic position according to the current practice for valve selection at the center.

Exclusion Criteria:

• Patients < 18 years of age
• Emergency surgery
• Pre-existing valve prosthesis
• Aortic root replacement
• Active endocarditis