The ShortCut™ Continued Access Study Protocol (ShortCut-CAS)

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

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

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis; Coronary; Obstruction; Valve-in-valve Procedures
• Intervention / Treatment: Device: Shortcut

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 artery ostia patency following leaflet split, in patients who are at risk for TAVR-induced coronary artery ostium obstruction following a ViV procedure.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Thousand Oaks, California, United States, 91360
      • Los Robles Regional Medical Center
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center /NYPH
  • Pennsylvania
    • Wormleysburg, Pennsylvania, United States, 17043
      • UPMC Pinnacle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shortcut; Splitting bioprosthetic aortic valve leaflets	Device: Shortcut; Splitting bioprosthetic aortic valve leaflets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ShortCut™ Device- and/or ShortCut™ Procedure-related: Mortality, Stroke	Primary safety endpoint, ShortCut™ device- and/or ShortCut™ procedure-related: Mortality, Stroke	discharge or at 7 days post-procedure, whichever occurs first
Number of Participants With Leaflet Splitting Success Using the Shortcut Device, Assessed by Echo and/or Angiography	Primary effectiveness endpoint, 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, Per VARC 3	Secondary safety endpoint, Rate of all cause mortality, per VARC 3	30 days post procedure
Rate of All-cause Stroke, Per VARC-3	Secondary safety endpoint, Rate of all-cause stroke, per VARC-3	30 days post procedure
Rate of Coronary Obstruction Per VARC-3	Secondary safety endpoint, Rate of coronary obstruction per VARC-3	30 days post procedure
Rate of MI With New Evidence of Coronary Artery Obstruction Requiring Intervention Per VARC-3	Secondary safety endpoint, Rate of MI with new evidence of coronary artery obstruction requiring intervention per VARC-3	30 days post procedure
-Rate of Major Vascular Complications Per VARC-3	Secondary safety endpoint, -Rate of major vascular complications per VARC-3	30 days post procedure
Rate of Cardiac Temponade Per VARC-3	Secondary safety endpoint, Rate of cardiac temponade per VARC-3	30 days post procedure
Rate of Acute Kidney Injury Per VARC-3	Secondary safety endpoint, Rate of Acute Kidney Injury per VARC-3	30 days post procedure
Access-related Type 3-4 Bleeding Per VARC-3	Secondary safety endpoint, Access-related type 3-4 bleeding per VARC-3	30 days post procedure
Rate of Freedom From Coronary Artery Intervention Related to the Intervened Leaflet	Secondary effectiveness endpoint, Rate of freedom from coronary artery intervention related to the intervened leaflet	30 days post procedure
Rate of Freedom From Coronary Artery Ostia Obstruction Related to the Intervened Leaflet	Secondary effectiveness endpoint, Rate of freedom from coronary artery ostia obstruction related to the intervened leaflet	30 days post procedure
Shortcut Technical Success	Technical success endpoint, Shortcut technical success - Successful access, delivery, and retrieval of the ShortCut™ device.	At exit from procedure room, immediately after the procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of All Cause Mortality Per VARC-3	Tertiary Safety Endpoint, Rate of all cause mortality per VARC-3	90 days post procedure
Rate of Stroke Per VARC-3	Tertiary Safety Endpoint, Rate of stroke per VARC-3	90 days post procedure
Rate of MI With New Evidence of Coronary Artery Obstruction Requiring Intervention Per VARC-3	Tertiary Safety Endpoint, Rate of MI with new evidence of coronary artery obstruction requiring intervention per VARC-3	90 days post procedure

Collaborators and Investigators

• Sponsor: Pi-cardia
• Investigators: Study Director: Hadas Givon, Pi-cardia

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2024
• Primary Completion (Actual): May 12, 2025
• Study Completion (Actual): May 12, 2025

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 3, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: TAVI; TAVR; continued access; Pi-Cardia; ViV; Shortcut
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Wounds and Injuries; Heart Diseases; Chemically-Induced Disorders; Heart Valve Diseases; Ventricular Outflow Obstruction; Poisoning; Aortic Valve Stenosis; Bites and Stings
• Other Study ID Numbers: S01-CLN-023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes