The ShortCut™ Study Protocol

Completed · Not applicable

Conditions studied: Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) Procedure

In brief

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 (ViV) transcatheter aortic valve replacement (TAVR) procedure for an approved ViV indication, and who are at risk for TAVR-induced coronary artery ostium obstruction.

Key facts

Study ID

NCT04952909

Run by

Pi-cardia

People needed

60

Starts

2022-01-21

Expected to finish

2023-12-31

Last updated by the study team

2025-02-03

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved valve-in-valve 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.

You may not qualify if…

• 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.
• Cerebrovascular Accident (CVA) or Transient Ischemic Attack (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.

Where it is running

• Tucson Medical Center — Tucson, Arizona, United States
• Smidt Heart Institute Cedars-Sinai Medical — Los Angeles, California, United States
• Kaiser Permanente - San Francisco Medical Center — San Francisco, California, United States
• Los Robles Regional Medical Center — Thousand Oaks, California, United States
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Morristown Medical Center — Morristown, New Jersey, United States
• Columbia University Medical Center — New York, New York, United States
• Carolinas Medical Center / Atrium Health — Charlotte, North Carolina, United States
• UPMC Pinnacle — Wormleysburg, Pennsylvania, United States
• Baylor Scott & White, The Heart Hospital Plano — Plano, Texas, United States
• Intermountain Medical Center — Murray, Utah, United States
• CHU de Bordeaux (Bordeaux University Hospital) — Bordeaux, France
• Institute Mutualiste Montsouris — Paris, France
• Clinique Pasteur — Toulouse, France
• German Heart Institute Berlin — Berlin, Germany
• University Hospital Hamburg — Hamburg, Germany
• Leipzig Heart Institute — Leipzig, Germany
• Sha'are Tzedek Medical Center — Jerusalem, Israel
• Rabin Medical Center — Petah Tikva, Israel
• Royal Sussex County Hospital — Brighton, United Kingdom
• Leeds General Infirmary — Leeds, United Kingdom

Full record on ClinicalTrials.gov

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