Status:
COMPLETED
The ShortCut™ Continued Access Study Protocol
Lead Sponsor:
Pi-cardia
Conditions:
Valve-in-valve Procedures
Aortic Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS).
Detailed Description
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 arter...
Eligibility Criteria
Inclusion
- 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
- 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.
- 8\. Need for emergency surgery for any reason. 9. Life expectancy is less than 1 year.
Key Trial Info
Start Date :
July 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2025
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06211296
Start Date
July 3 2024
End Date
May 12 2025
Last Update
November 17 2025
Active Locations (4)
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1
Los Robles Regional Medical Center
Thousand Oaks, California, United States, 91360
2
Morristown Medical Center
Morristown, New Jersey, United States, 07960
3
Columbia University Medical Center /NYPH
New York, New York, United States, 10032
4
UPMC Pinnacle
Wormleysburg, Pennsylvania, United States, 17043