The ShortCut™ Study Protocol

NCT04952909 | Completed Results DMC

• 1 other identifier: S01-CLN-002
• Study Type: interventional
• Target: 60
• Locations: 5 countries
• Sites: 23

Brief Summary

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.

Conditions

Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) Procedure

Outcome Measures

Primary Outcomes (2)

• (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 Outcomes (11)

• (Number of Patients With) All-cause Mortality

  30 days post procedure

• (Number of Patients With) All-cause Stroke

  30 days post procedure

• (Number of Patients With) Coronary Obstruction

  30 days post procedure

• (Number of Patients With) Myocardial Infarction With New Evidence of Coronary Artery Obstruction Requiring Intervention

  30 days post procedure

• (Number of Patients With) Major Vascular Complications

  30 days post procedure

Other Outcomes (3)

• (Number of Patients With) All-cause Mortality

  90 days post procedure

• (Number of Patients With) Stroke

  90 days post procedure

• (Number of Patients With) Myocardial Infarction With New Evidence of Coronary Artery Obstruction Requiring Intervention

  90 days post procedure

Study Arms (1)

ShortCut™

EXPERIMENTAL

Device: ShortCut™

Interventions

ShortCut™ DEVICE

Splitting bioprosthetic aortic valve leaflets

ShortCut™

Eligibility Criteria

• Age: 18 Years - 100 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pi-cardia: lead

Study Sites (23)

Tucson Medical Center

Tucson, Arizona, 85712, United States

Location

Smidt Heart Institute Cedars-Sinai Medical

Los Angeles, California, 90048, United States

Location

Kaiser Permanente - San Francisco Medical Center

San Francisco, California, 94115, United States

Location

Los Robles Regional Medical Center

Thousand Oaks, California, 91360, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Carolinas Medical Center / Atrium Health

Charlotte, North Carolina, 28204, United States

Location

UPMC Pinnacle

Wormleysburg, Pennsylvania, 17043, United States

Location

Baylor Scott & White, The Heart Hospital Plano

Plano, Texas, 75093, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

CHU de Bordeaux (Bordeaux University Hospital)

Bordeaux, France

Location

Institute Mutualiste Montsouris

Paris, France

Location

Clinique Pasteur

Toulouse, France

Location

German Heart Institute Berlin

Berlin, Germany

Location

University Hospital Hamburg

Hamburg, Germany

Location

Leipzig Heart Institute

Leipzig, Germany

Location

Sha'are Tzedek Medical Center

Jerusalem, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Royal Sussex County Hospital

Brighton, United Kingdom

Location

Leeds General Infirmary

Leeds, United Kingdom

Location

Results Point of Contact

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

hadas@pi-cardia.net

+972-8-9484800

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• 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: June 28, 2021
• First Posted: July 7, 2021
• Study Start: January 21, 2022
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3); IL (2); US (13); GB (2); DE (3)