The ShortCut™ Study Protocol

A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ Device (The ShortCut™ Study)

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

Study Overview

• Status: Completed
• Conditions: Risk of Coronary Obstruction Following TAVR Procedure
• Intervention / Treatment: Device: ShortCut™

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Merav Gat; Phone Number: +97289484800; Email: merav@pi-cardia.net

Study Locations

• France
  • Bordeaux, France
    • CHU de Bordeaux (Bordeaux University Hospital)
  • Paris, France
    • Institute Mutualiste Montsouris
  • Toulouse, France
    • Clinique Pasteur
• Germany
  • Berlin, Germany
    • German Heart Institute Berlin
  • Hamburg, Germany
    • University Hospital Hamburg
  • Leipzig, Germany
    • Leipzig Heart Institute
• Israel
  • Jerusalem, Israel
    • Sha'are Tzedek Medical Center
  • Petach Tikva, Israel
    • Rabin Medical Center
• United Kingdom
  • Brighton, United Kingdom
    • Royal Sussex County Hospital
  • Leeds, United Kingdom
    • Leeds General Infirmary
• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Tucson Medical Center
  • California
    • Los Angeles, California, United States, 90048
      • Smidt Heart Institute Cedars-Sinai Medical
    • San Francisco, California, United States, 94115
      • Kaiser Permanente - San Francisco Medical Center
    • Thousand Oaks, California, United States, 91360
      • Los Robles Regional Medical Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Medical Center / Atrium Health
  • Pennsylvania
    • Wormleysburg, Pennsylvania, United States, 17043
      • UPMC Pinnacle
  • Texas
    • Plano, Texas, United States, 75093
      • Baylor Scott & White, The Heart Hospital Plano
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.
• CVA or 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.

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™	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 and all cause stroke		Discharge or at 7 days post-procedure, whichever occurs first
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	(VARC-3)	30 days post procedure
Rate of all-cause stroke	(VARC-3)	30 days post procedure
Rate of coronary obstruction	(VARC-3)	30 days post procedure
Rate of myocardial infarction with new evidence of coronary artery obstruction requiring intervention	(VARC-3)	30 days post procedure
Rate of major vascular complications	(VARC-3)	30 days post procedure
Rate of cardiac tamponade	(VARC-3)	30 days post procedure
Rate of acute kidney injury	(VARC-3)	30 days post procedure
Rate of access-related type 3-4 bleeding	(VARC-3)	30 days post procedure
Rate of freedom from coronary artery ostia obstruction related to the intervened leaflet		30 days post index procedure
Rate of freedom from coronary artery intervention related to the intervened leaflet		30 days post index procedure
ShortCut™ technical success		At exit from procedure room

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of all-cause mortality	(VARC-3)	90 days post procedure
Rate of stroke	(VARC-3)	90 days post procedure
Rate of myocardial infarction with new evidence of coronary artery obstruction requiring intervention	(VARC-3)	90 days post procedure

Collaborators and Investigators

• Sponsor: Pi-cardia

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2022
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: June 28, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: S01-CLN-002

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: No