The ShortCut™ Continued Access Study Protocol

The continued access study will be used to collect additional safety and effectiveness data of the ShortCut™ device for splitting bioprosthetic aortic valve leaflets, and to demonstrate coronary artery ostia patency following leaflet split, in patients who are at risk for TAVR-induced coronary artery ostium obstruction following a ViV procedure.

Inclusion criteria

• Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved ViV indication due to a failed bioprosthetic valve.
• Patient is at risk for TAVR-induced coronary artery ostium obstruction.
• 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

• 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.
• 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.
• CVA or TIA ≤ 6 months prior to index procedure.
• History of a myocardial infarction (MI) ≤ 6 weeks prior to index procedure.
• Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance.
• LVEF < 30%.
• Ongoing severe infection or sepsis.
• Patient has renal insufficiency or is on chronic dialysis.

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