CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement

A prospective, single-arm, controlled, multicenter study. Additional subjects may be enrolled
in a bicuspid registry.

Inclusion Criteria:

1. Severe, calcific AS meeting the following transthoracic echocardiogram (TTE) criteria:
AV area ≤ 1.0 cm2 OR AV area index ≤ 0.6 cm2/m2, Jet velocity ≥ 4.0 m/s OR mean
gradient ≥ 40 mmHg

2. NYHA functional class ≥ II

3. Judged by the Heart Team to be at intermediate risk for open surgical therapy (i.e.,
predicted risk of surgical mortality ≥ 3% and < 8% at 30 days, based on the Society of
Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the
risk calculator)

4. The subject has been informed of the nature of the study, agrees to its provisions and
has provided written informed consent as approved by the Institutional Review
Board/Ethics Committee of the respective clinical site.

Exclusion Criteria:

1. Pre-existing mechanical or bioprosthetic valve in any position. (Of note, mitral ring
is not an exclusion).

2. Known hypersensitivity to Nitinol (nickel or titanium)

3. Severe aortic regurgitation (> 3+)

4. Severe mitral regurgitation (> 3+) or ≥ moderate stenosis

5. Evidence of an acute myocardial infarction ≤ 30 days before the valve implant
procedure

6. Stroke or transient ischemic attack within 90 days of the valve implant procedure

7. Severe lung disease or currently on home oxygen

8. Severe pulmonary hypertension

9. History of cirrhosis or any active liver disease