The ShortCut™ Continued Access Study Protocol

NCT06211296 | Completed Results FDA Device

• 1 other identifier: S01-CLN-023
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Valve-in-valve Procedures; Aortic Stenosis; Coronary; Obstruction

Keywords

TAVI; Pi-Cardia; TAVR; ViV; continued access; Shortcut

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Rate of All Cause Mortality, Per VARC 3

  30 days post procedure

• Rate of All-cause Stroke, Per VARC-3

  30 days post procedure

• 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

  30 days post procedure

• -Rate of Major Vascular Complications Per VARC-3

  30 days post procedure

Other Outcomes (3)

• Rate of All Cause Mortality Per VARC-3

  90 days post procedure

• 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

  90 days post procedure

Study Arms (1)

Shortcut

EXPERIMENTAL

Splitting bioprosthetic aortic valve leaflets

Device: Shortcut

Interventions

Shortcut DEVICE

Splitting bioprosthetic aortic valve leaflets

Shortcut

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Pi-cardia: lead

Study Sites (4)

Los Robles Regional Medical Center

Thousand Oaks, California, 91360, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Columbia University Medical Center /NYPH

New York, New York, 10032, United States

Location

UPMC Pinnacle

Wormleysburg, Pennsylvania, 17043, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Bites and Stings

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Results Point of Contact

• Title: Hadas Givon, VP CA/RA
• Organization: Pi-Cardia

hadas@pi-cardia.net

+972-8-9484800

Study Officials

• Hadas Givon

  Pi-cardia

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: July 3, 2024
• Primary Completion: May 12, 2025
• Study Completion: May 12, 2025
• Last Updated: November 17, 2025
• Results First Posted: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)