A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ Device (The ShortCut™ Study)
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ device for splitting bioprosthetic aortic valve leaflets in patients who are presented for a valve-in-valve transcatheter aortic valve replacement (TAVR) procedure for an approved ViV indication, and who are at risk for TAVR-induced coronary artery ostium obstruction.
Additional Principal Investigator for this trial: Andrew Rassi, San Francisco, CA.
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- Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved ViV indication due to a failed bioprosthetic valve.
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- 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.
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- An excessive aortic valve leaflet Calcium morphology or anatomy not suitable for the use of the ShortCut™ device.
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- Coronary, carotid or vertebral artery disease that, in the opinion of the local Heart Team, should be treated
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- or treatment of such disease = 1 month prior to index procedure.
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- CVA or TIA = 6 months prior to index procedure, or severe neurological disability.
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- Myocardial infarction (MI) = 6 weeks prior to index procedure.
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- Hemodynamic or respiratory instability.
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- Left ventricle ejection fraction \< 30%.
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- Ongoing severe infection, sepsis or endocarditis.
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- Need for emergency surgery for any reason.
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- Life expectancy is less than 1 year.
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