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:

1. 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.

2. Subject is of legal age in the country where the subject is enrolled.

3. Subject must be willing and able to provide written informed consent to participate in
this study.

4. Subject must be willing and able to comply with all follow-up requirements.

Exclusion Criteria:

1. Subject undergoes a concomitant procedure of mitral or tricuspid valve replacement at
the time of the Trifecta GT valve implantation surgery.

2. Subject has contraindication for cardiac surgery.

3. Subject is pregnant. Pregnancy will be assessed by the subject informing the
physicians.

4. 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).

5. Subject has had a stroke or transient ischemic attack within 6 months prior to the
planned valve implantation surgery.

6. Subject is undergoing renal dialysis.

7. Subject has a history of active drug addiction, active alcohol abuse, or psychiatric
hospital admission for psychosis within the prior 2 years.

8. Subject has a documented thrombus in the left atrium or left ventricle at the time of
the valve implantation surgery.

9. Subject has a left ventricular ejection fraction < 30%.

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 Subject previously enrolled in the Trifecta GT PMCF study and withdrawn (a subject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

11. Preoperative evaluation indicates other significant cardiovascular abnormalities such
as aortic dissection or ventricular aneurysm.

12. Subject has a life expectancy less than 2 years.