TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease

Exclusion Criteria

• •1. Patients who have known hypersensitivity or contraindication to Nitinol (titanium and/or nickel), an anti-coagulation/anti-platelet regimen or contrast medium that cannot be managed with premedication
• •2. Patients who have active bacterial endocarditis or other active infections
• •3. Pediatric (\<18 years) and/or pregnant/nursing patients
• •4. Congenital/functional unicuspid, bicuspid or quadricuspid native aortic valve morphology
• •5. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
• •6. Echocardiographic evidence of current left heart thrombus
• •7. Hypertrophic cardiomyopathy with or without obstruction.
• •8. Access vessel characteristics that would preclude safe placement of the JenaValve 20Fr introducer sheath, such as severe obstructive calcification, severe tortuosity, or vessel diameter \<7mm.