The ShortCut™ Study Protocol

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ Device (The ShortCut™ Study)

Conditions
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Risk of Coronary Obstruction Following TAVR Procedure

Intervention / Treatment
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* Device: ShortCut™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved ViV indication due to a failed bioprosthetic valve. 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 or anatomy not suitable for the use of the ShortCut™ device. Coronary, carotid or vertebral artery disease that, in the opinion of the local Heart Team, should be treated; or treatment of such disease ≤ 1 month prior to index procedure. CVA or TIA ≤ 6 months prior to index procedure, or severe neurological disability. Myocardial infarction (MI) ≤ 6 weeks prior to index procedure. Hemodynamic or respiratory instability. Left ventricle ejection fraction < 30%. Ongoing severe infection, sepsis or endocarditis. Renal insufficiency Need for emergency surgery for any reason. Life expectancy is less than 1 year.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ShortCut™<br> | Device: ShortCut™<br>* Splitting bioprosthetic aortic valve leaflets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ShortCut™ device- and/or ShortCut™ procedure-related mortality and all cause stroke |  | Discharge or at 7 days post-procedure, whichever occurs first | 
| Leaflet splitting success using the ShortCut™ device | Assessed by echo and/or angiography | Intra-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of all-cause mortality | (VARC-3) | 30 days post procedure | 
| Rate of all-cause stroke | (VARC-3) | 30 days post procedure | 
| Rate of coronary obstruction | (VARC-3) | 30 days post procedure | 
| Rate of myocardial infarction with new evidence of coronary artery obstruction requiring intervention | (VARC-3) | 30 days post procedure | 
| Rate of major vascular complications | (VARC-3) | 30 days post procedure | 
| Rate of cardiac tamponade | (VARC-3) | 30 days post procedure | 
| Rate of acute kidney injury | (VARC-3) | 30 days post procedure | 
| Rate of access-related type 3-4 bleeding | (VARC-3) | 30 days post procedure | 
| Rate of freedom from coronary artery ostia obstruction related to the intervened leaflet |  | 30 days post index procedure | 
| Rate of freedom from coronary artery intervention related to the intervened leaflet |  | 30 days post index procedure | 
| ShortCut™ technical success |  | At exit from procedure room |