Clinical Trials

Inclusion Criteria:

1. Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate
insufficiency

2. Bioprosthetic valve size suitable for SAPIEN X4 THV

3. NYHA functional class ≥ II

4. Heart Team agrees the subject is at high or greater surgical risk

5. The subject has been informed of the nature of the study, agrees to its provisions and
has provided written informed consent.

Exclusion Criteria:

1. Anatomical characteristics that would preclude safe femoral placement of the
introducer sheath or safe passage of the delivery system

2. Failing valve has moderate or severe paravalvular regurgitation

3. Failing valve is unstable, rocking, or not structurally intact

4. Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean
gradient > 20 mmHg at the end of the index procedure for implantation of the original
valve

5. Increased risk of THV embolization

6. Surgical or transcatheter valve in the mitral position

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

8. Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months

9. Left ventricular ejection fraction < 20%

10. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation

11. Increased risk of coronary artery obstruction after THV implantation

12. Myocardial infarction within 30 days prior to the study procedure

13. Hypertrophic cardiomyopathy with subvalvular obstruction

14. Subjects with planned concomitant ablation for atrial fibrillation

15. Clinically significant coronary artery disease requiring revascularization

16. Any surgical or transcatheter procedure within 30 days prior to the study procedure.
Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not
considered an exclusion.

17. Any planned surgical or transcatheter intervention to be performed within 30 days
following the study procedure

18. Endocarditis within 180 days prior to the study procedure

19. Stroke, transient ischemic attack or neurological signs and symptoms attributed to
carotid or vertebrobasilar disease within 90 days prior to the study procedure

20. Hemodynamic or respiratory instability requiring inotropic or mechanical support
within 30 days prior to the study procedure

21. Renal insufficiency and/or renal replacement therapy

22. Leukopenia, anemia, thrombocytopenia

23. Inability to tolerate or condition precluding treatment with antithrombotic therapy

24. Hypercoagulable state or other condition that increases risk of thrombosis

25. Absolute contraindications or allergy to iodinated contrast that cannot be adequately
treated with premedication

26. Subject refuses blood products

27. Body mass index > 50 kg/m^2

28. Estimated life expectancy < 24 months

29. Female who is pregnant or lactating

30. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that
could confound endpoint assessments

31. Participating in another investigational drug or device study that has not reached its
primary endpoint

32. Subject considered to be part of a vulnerable population

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/13/23. Questions regarding updates should be directed to the study team contact.