Behavior of Valve Leaflets

This is a prospective, interventional, multi-center trial to report the overall incidence of
reduced leaflet motion identified by CT imaging in patients receiving a commercially approved
LivaNova bioprosthetic aortic heart valve up to 1 year post implant, on patients that are off
anticoagulation for at least 30 days. A minimum of 75 subjects with evaluable 4D CT scans
will be enrolled at approximately 11 investigational sites where the devices are commercially
available. For asymptomatic subjects, PIs and subjects will be blinded from the CT imaging
results and from the Core Lab findings.

Inclusion Criteria:

1. The subject has been successfully implanted with a commercially approved LivaNova
bioprosthetic valve according to the instructions for use (IFU)

2. The subject has signed the informed consent.

3. The subject is at least 18 years of age at the time of implant and consent signature

4. The subject will be available for post-operative follow-up through one year

Exclusion Criteria:

1. The subject has a planned concomitant cardiac procedure other than coronary artery
bypass graft (CABG) and septal myectomy, including MAZE procedures, atrial
fibrillation surgery, and left atrial appendage exclusion or resection, or has a
prosthetic heart valve or annuloplasty ring in any position

2. The subject has any medical condition requiring long term (> 6 months) anticoagulation
or dual antiplatelet therapy

3. The subject has any clinical condition precluding the use of CT imaging with contrast

4. The subject had a stroke or myocardial infarction (STEMI and NSTEMI) within 30 days of
the planned valve implant surgery

5. The subject has active endocarditis, myocarditis, or sepsis

6. The subject is in cardiogenic shock manifested by low cardiac output and needing
hemodynamic support

7. The subject is already included in another clinical trial that could confound the
results of this clinical investigation