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This is a post-market, prospective, multicenter, single-arm post market study sponsored by Pi-Cardia Ltd. The ShortCut is indicated for use as a splitting device of bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures for subjects at risk for coronary obstruction. The ShortCut has been cleared by FDA under DEN240017, and this study is a post-market evaluation of the ShortCut per the FDA cleared indications for use.
The objectives of the study are:
Data will be collected, where available, from the subjects' medical records at the following time-points: baseline, index procedure, pre-discharge, and 30 days post-procedure.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transfemoral catheter designed to split the bioprosthetic aortic valve leaflets prior to TAVR | Device | A transfemoral catheter designed to split the bioprosthetic aortic valve leaflets prior to TAVR, to reduce the risk of coronary obstruction and coronary access compromise and enable a valve-in-valve procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Assessment | Each of the following ShortCut- and/or ShortCut procedure-related adverse events at initial cardiac hospitalization discharge or 7 days post-procedure, whichever occurs first, as assessed by the Clinical Events Committee (CEC):
| At discharge or 7 days post-procedure, whichever occurs first |
| Primary Effectiveness Assessment | Rate of coronary patency of the coronary ostium adjacent to the treated leaflet by contrast aortography after TAVR implantation as assessed by a core lab. | Immediately after TAVR procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients ≥22 years old that plan to undergo a ViV TAVR procedure at risk for coronary obstruction.
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