Trifecta™ GT Post Market Clinical Follow-up

You may not qualify if:

• Subject undergoes a concomitant procedure of mitral or tricuspid valve replacement at the time of the Trifecta GT valve implantation surgery.
• Subject has contraindication for cardiac surgery.
• Subject is pregnant. Pregnancy will be assessed by the subject informing the physicians.
• Subject has active endocarditis (subjects who have previously experienced endocarditis must have two documented negative blood culture results while off antibiotic therapy prior to the valve implantation surgery).
• Subject has had a stroke or transient ischemic attack within 6 months prior to the planned valve implantation surgery.
• Subject is undergoing renal dialysis.
• Subject has a history of active drug addiction, active alcohol abuse, or psychiatric hospital admission for psychosis within the prior 2 years.
• Subject has a documented thrombus in the left atrium or left ventricle at the time of the valve implantation surgery.
• Subject has a left ventricular ejection fraction \< 30%.
• Subject previously enrolled in the Trifecta GT PMCF study and withdrawn (a subject cannot be enrolled twice in this study).
• Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.
• Subject has a life expectancy less than 2 years.