A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
8
Splitting bioprosthetic aortic valve leaflets
Los Robles Regional Medical Center
Thousand Oaks, California, United States
Morristown Medical Center
Morristown, New Jersey, United States
Columbia University Medical Center /NYPH
New York, New York, United States
UPMC Pinnacle
Wormleysburg, Pennsylvania, United States
ShortCut™ Device- and/or ShortCut™ Procedure-related: Mortality, Stroke
Primary safety endpoint, ShortCut™ device- and/or ShortCut™ procedure-related: Mortality, Stroke
Time frame: discharge or at 7 days post-procedure, whichever occurs first
Number of Participants With Leaflet Splitting Success Using the Shortcut Device, Assessed by Echo and/or Angiography
Primary effectiveness endpoint, Leaflet splitting success using the Shortcut Device, assessed by echo and/or angiography
Time frame: Intra-procedure
Rate of All Cause Mortality, Per VARC 3
Secondary safety endpoint, Rate of all cause mortality, per VARC 3
Time frame: 30 days post procedure
Rate of All-cause Stroke, Per VARC-3
Secondary safety endpoint, Rate of all-cause stroke, per VARC-3
Time frame: 30 days post procedure
Rate of Coronary Obstruction Per VARC-3
Secondary safety endpoint, Rate of coronary obstruction per VARC-3
Time frame: 30 days post procedure
Rate of MI With New Evidence of Coronary Artery Obstruction Requiring Intervention Per VARC-3
Secondary safety endpoint, Rate of MI with new evidence of coronary artery obstruction requiring intervention per VARC-3
Time frame: 30 days post procedure
-Rate of Major Vascular Complications Per VARC-3
Secondary safety endpoint, -Rate of major vascular complications per VARC-3
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Time frame: 30 days post procedure
Rate of Cardiac Temponade Per VARC-3
Secondary safety endpoint, Rate of cardiac temponade per VARC-3
Time frame: 30 days post procedure
Rate of Acute Kidney Injury Per VARC-3
Secondary safety endpoint, Rate of Acute Kidney Injury per VARC-3
Time frame: 30 days post procedure
Access-related Type 3-4 Bleeding Per VARC-3
Secondary safety endpoint, Access-related type 3-4 bleeding per VARC-3
Time frame: 30 days post procedure
Rate of Freedom From Coronary Artery Intervention Related to the Intervened Leaflet
Secondary effectiveness endpoint, Rate of freedom from coronary artery intervention related to the intervened leaflet
Time frame: 30 days post procedure
Rate of Freedom From Coronary Artery Ostia Obstruction Related to the Intervened Leaflet
Secondary effectiveness endpoint, Rate of freedom from coronary artery ostia obstruction related to the intervened leaflet
Time frame: 30 days post procedure
Shortcut Technical Success
Technical success endpoint, Shortcut technical success - Successful access, delivery, and retrieval of the ShortCut™ device.
Time frame: At exit from procedure room, immediately after the procedure