The ShortCut™ Continued Access Study Protocol

Completed · Not applicable

Conditions studied: Valve-in-valve Procedures, Aortic Stenosis, Coronary; Obstruction

In brief

A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS).

Key facts

Study ID

NCT06211296

Run by

Pi-cardia

People needed

8

Starts

2024-07-03

Expected to finish

2025-05-12

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Need for emergency surgery for any reason. 9. Life expectancy is less than 1 year.

Where it is running

• 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

Full record on ClinicalTrials.gov

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