Perceval S Aortic Heart Valve Study- North America

Exclusion Criteria

• •1. The subject has preexisting valve prosthesis or annuloplasty ring in the mitral, pulmonic or tricuspid position.
• •2. The subject requires a double or multiple valve replacement or repair of the mitral, tricuspid, or pulmonic valve.
• •3. The subject has a previously implanted PERCEVAL valve that requires replacement.
• •4. Subjects requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass.
• •5. The subject has active endocarditis.
• •6. Subjects with active myocarditis
• •7. The subject is or will be participating in a concomitant research study of an investigational product.
• •8. Subjects with aneurysmal dilation or dissection of the ascending aortic wall.
• •9. The subject is a minor, drug abuser, alcohol abuser, prison inmate, institutionalized, or is unable to give informed consent.
• •10. The subject has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the patient.
• •11. Subjects with known hypersensitivity to nickel alloys.
• •12. The subject is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism.
• •13. The subject has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized ≥30 days prior to the planned valve implant surgery.
• •14. Subject is known to be noncompliant or is unlikely to complete the study.
• •15. Subjects with an aortic root enlargement, where the ratio between the diameter of the sino-tubular junction and the annulus diameter, assessed by TTE, is \> 1.3.