Trifecta™ GT Post Market Clinical Follow-up

The study is a prospective multi-center evaluation of approximately 350 subjects implanted with a St. Jude Medical (SJM) Trifecta™ GT valve. It will be conducted in approximately 35 sites worldwide.

Subjects will be followed for 5 years. The total duration of the study is expected to be 6 years, assuming all subjects are enrolled within 1 year of study initiation. To ensure enrollment balance across sites, no individual site can enroll more than 10% of the sample size (n=35 subjects) without prior approval from the sponsor.

Inclusion criteria

• Subject is a candidate for surgical aortic valve replacement per current guidelines and is intended to be implanted with a St. Jude Medical Trifecta GT valve.
• Subject is of legal age in the country where the subject is enrolled.
• Subject must be willing and able to provide written informed consent to participate in this study.
• Subject must be willing and able to comply with all follow-up requirements.

Exclusion criteria

• 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• Subject previously enrolled in the Trifecta GT PMCF study and withdrawn (a subject cannot be enrolled twice in this study).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.