Ensayos clínicos

Inclusion Criteria:

1. Failing surgical or transcatheter bioprosthetic valve in the aortic position
demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.

2. Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm.

3. NYHA Functional Class ≥ II.

4. Heart Team agrees the patient is low to intermediate risk.

5. Heart Team agrees valve implantation will likely benefit the patient.

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

Exclusion Criteria:

1. Surgical or transcatheter valve in the mitral position (mitral rings are not an
exclusion)

2. Severe regurgitation (> 3+) or stenosis of any other valve

3. Failing valve has moderate or severe paravalvular regurgitation

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

5. Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.

6. Increased risk of embolization of THV

7. Known bioprosthetic valve with residual mean gradient > 20 mmHg at the end of the
index procedure for implantation of the original valve

8. Iliofemoral vessel characteristics that would preclude safe placement of the
introducer sheath (Transfemoral)

9. Anatomical characteristics that would preclude safe access to the ascending aorta
(Transaortic)

10. Anatomical characteristics that would preclude safe access to the apex (Transapical)

11. Evidence of an acute myocardial infarction ≤ 30 days before enrollment

12. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is
performed within 30 days prior to the index procedure. Implantation of a permanent
pacemaker or implantable cardioverter defibrillator is not considered an exclusion.

13. Patients with planned concomitant surgical or transcatheter ablation for Atrial
Fibrillation

14. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or
hypercoagulable states

15. Untreated clinically significant coronary artery disease requiring revascularization

16. Hemodynamic or respiratory instability requiring inotropic support, mechanical
ventilation, or mechanical heart assistance within 30 days of enrollment

17. Emergency interventional/surgical procedures within 30 days prior to the procedure

18. Any planned surgical, percutaneous coronary, or peripheral procedure to be performed
within the 30-day follow-up from the procedure

19. Hypertrophic cardiomyopathy with obstruction

20. LVEF < 30%

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

22. Inability to tolerate or condition precluding treatment with
antithrombotic/anticoagulation therapy during or after the valve implant procedure

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

24. Stroke or transient ischemic attack within 90 days of enrollment

25. Symptomatic carotid or vertebral artery disease or successful treatment of carotid
stenosis within 30 days of enrollment

26. Renal insufficiency and/or renal replacement therapy at the time of screening

27. Active bacterial endocarditis within 180 days of the procedure

28. Patient refuses blood products

29. Estimated life expectancy < 24 months

30. Positive urine or serum pregnancy test in female subjects of childbearing potential

31. Currently participating in an investigational drug or another device study

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

Eligibility last updated 8/3/22. Questions regarding updates should be directed to the study team contact