The ShortCut™ Continued Access Study Protocol
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS). 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 artery ostia patency following leaflet split, in patients who are at risk for TAVR-induced coronary artery ostium obstruction following a ViV procedure.
Conditions:
🦠 Valve-in-valve Procedures 🦠 Aortic Stenosis 🦠 Coronary; Obstruction
🗓️ Study Start (Actual) 3 July 2024
🗓️ Primary Completion (Estimated) April 2025
✅ Study Completion (Estimated) September 2025
👥 Enrollment (Estimated) 50
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Thousand Oaks, California, United States
📍 Morristown, New Jersey, United States
📍 New York, New York, United States
📍 Wormleysburg, Pennsylvania, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Patient is planned to undergo a percutaneous valve-in-valve procedure for an approved ViV indication due to a failed bioprosthetic valve.
    • 2. Patient is at risk for TAVR-induced coronary artery ostium obstruction.
    • 3. 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:

    • 1. 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.
    • 2. 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.
    • 3. CVA or TIA ≤ 6 months prior to index procedure.
    • 4. History of a myocardial infarction (MI) ≤ 6 weeks prior to index procedure.
    • 5. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance.
    • 6. LVEF \< 30%.
    • 7. Ongoing severe infection or sepsis.
    • 8. 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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 8 January 2024
  • First Submitted that Met QC Criteria 8 January 2024
  • First Posted 18 January 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 July 2024
  • Last Update Posted 24 July 2024
  • Last Verified July 2024