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 (ViV) 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 Transcatheter Aortic Valve Replacement (TAVR) Procedure
• Intervention / Treatment: Device: ShortCut™

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

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 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.

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.
• 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.

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
(Number of Patients With) ShortCut™ Device- and/or ShortCut™ Procedure-related Mortality and All Cause Stroke		Discharge or at 7 days post-procedure, whichever occurs first
(Number of Patients With) Leaflet Splitting Success Using the ShortCut™ Device	Assessed by echo and/or angiography	Intra-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Number of Patients With) All-cause Mortality	(VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.	30 days post procedure
(Number of Patients With) All-cause Stroke	(VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.	30 days post procedure
(Number of Patients With) Coronary Obstruction	(VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.	30 days post procedure
(Number of Patients With) Myocardial Infarction With New Evidence of Coronary Artery Obstruction Requiring Intervention	(VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.	30 days post procedure
(Number of Patients With) Major Vascular Complications	(VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.	30 days post procedure
(Number of Patients With) Cardiac Tamponade	(VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.	30 days post procedure
(Number of Patients With) Acute Kidney Injury	(Acute kidney injury stage 3-4 per VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.; Acute kidney injury stage 3:Increase in serum creatinine >300% (>3.0 X increase) within 7 days compared with baselineSerum creatinine ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of ≥0.5 mg/dL (≥44 mmol/L); Acute kidney injury stage 4:AKI requiring new temporary or permanent renal replacement therapy No differentiation was made between the stages when assessing the outcome.	30 days post procedure
(Number of Patients With) Access-related Type 3-4 Bleeding	(VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.; Type 3 bleeding:Overt bleeding causing hypovolemic shock or severe hypotension (systolic blood pressure <90 mmHg lasting >30 min and not responding to volume resuscitation) or requiring vasopressors or surgery (BARC 3b)Overt bleeding requiring reoperation, surgical exploration, or reintervention for the purpose of controlling bleeding (BARC 3b, BARC 4)Overt bleeding requiring a transfusion of ≥5 units of whole blood/red blood cells (BARC 3a)Overt bleeding associated with a hemoglobin drop ≥5 g/dL (≥3.1 mmol/L) (BARC 3b); Type 4 bleeding:Overt bleeding leading	30 days post procedure
(Number of Patients With) Freedom From Coronary Artery Ostia Obstruction Related to the Intervened Leaflet		30 days post index procedure
(Number of Patients With) Freedom From Coronary Artery Intervention Related to the Intervened Leaflet		30 days post index procedure
(Number of Patients With) ShortCut™ Technical Success	Technical success is defined as a composite of the following: Successful access, delivery, and retrieval of the ShortCut™ device; Freedom from ShortCut™ device- and/or ShortCut™ procedure-related mortality; Freedom from ShortCut™ device- and/or ShortCut™ procedure-related: Surgery or intervention, Major vascular or access-related complications, Cardiac structural complication.	At exit from procedure room

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Number of Patients With) All-cause Mortality	(VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.	90 days post procedure
(Number of Patients With) Stroke	(VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.	90 days post procedure
(Number of Patients With) Myocardial Infarction With New Evidence of Coronary Artery Obstruction Requiring Intervention	(VARC-3) The Valve Academic Research Consortium (VARC) is intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. VARC-3 provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.	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): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 30, 2025
• 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