The ShortCut™ Continued Access Study Protocol

Inclusion Criteria:

1. Patient is planned to undergo a percutaneous valve-in-valve procedure for anapproved 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 orsubject's legal representative, according to local regulations, prior to initiationof any study mandated procedure.

Exclusion Criteria:

1. An excessive aortic valve leaflet Calcium morphology, such as diffuse massivecalcification at the targeted leaflet for splitting or anatomy not suitable for theuse 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 indexprocedure.

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, mechanicalventilation or mechanical heart assistance.

6. LVEF < 30%.

7. Ongoing severe infection or sepsis.

8. Patient has renal insufficiency or is on chronic dialysis.

9. Need for emergency surgery for any reason. 9. Life expectancy is less than 1 year.