Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

The purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.

This is a prospective, non-randomized, non-controlled observational clinical trial. Up to 200 subjects will be enrolled at up to 6 participating clinical sites. The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic valve. Patients will be followed and assessed after implant for up to 5 years.

Inclusion Criteria:

• 18 years or older
• Require replacement of aortic valve
• Signed informed consent
• Willing to return to study site for follow-up visits

Exclusion Criteria:

• Active endocarditis/myocarditis (< 3 months)
• Myocardial infarction (< 30 days)
• Renal insufficiency/ End-stage renal disease
• Life expectancy (< 1 year)
• Requires multiple valve replacement/repair
• Requiring emergent aortic valve surgery
• Pregnant or lactating