Description
Inclusion Criteria:
- 1. Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved ViV indication due to a failed bioprosthetic valve.
- 2. Patient is at risk for TAVR-induced coronary artery ostium obstruction.
- 3. Written informed consent to participate in the study obtained from the subject or subject's legal representative, according to local regulations, prior to initiation of any study mandated procedure.
Exclusion Criteria:
- 1. An excessive aortic valve leaflet Calcium morphology, such as diffuse massive calcification at the targeted leaflet for splitting or anatomy not suitable for the use of the ShortCut™ device, as determined by the CT measurements.
- 2. Carotid or vertebral artery disease that, in the opinion of the local Heart Team, should be treated; or treatment of carotid stenosis ≤ 1 month prior to index procedure.
- 3. CVA or TIA ≤ 6 months prior to index procedure.
- 4. History of a myocardial infarction (MI) ≤ 6 weeks prior to index procedure.
- 5. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance.
- 6. LVEF \< 30%.
- 7. Ongoing severe infection or sepsis.
- 8. Patient has renal insufficiency or is on chronic dialysis.
- 8. Need for emergency surgery for any reason. 9. Life expectancy is less than 1 year.
Ages Eligible for Study:
18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
No