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

May 25, 2026 updated by: Pi-cardia

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Shortcut
Splitting bioprosthetic aortic valve leaflets
Device: Shortcut
Splitting bioprosthetic aortic valve leaflets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ShortCut™ Device- and/or ShortCut™ Procedure-related: Mortality, Stroke
Time Frame: discharge or at 7 days post-procedure, whichever occurs first
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
Time Frame: Intra-procedure
Primary effectiveness endpoint, Leaflet splitting success using the Shortcut Device, assessed by echo and/or angiography
Intra-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of All Cause Mortality, Per VARC 3
Time Frame: 30 days post procedure
Secondary safety endpoint, Rate of all cause mortality, per VARC 3
30 days post procedure
Rate of All-cause Stroke, Per VARC-3
Time Frame: 30 days post procedure
Secondary safety endpoint, Rate of all-cause stroke, per VARC-3
30 days post procedure
Rate of Coronary Obstruction Per VARC-3
Time Frame: 30 days post procedure
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
Time Frame: 30 days post procedure
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
Time Frame: 30 days post procedure
Secondary safety endpoint, -Rate of major vascular complications per VARC-3
30 days post procedure
Rate of Cardiac Temponade Per VARC-3
Time Frame: 30 days post procedure
Secondary safety endpoint, Rate of cardiac temponade per VARC-3
30 days post procedure
Rate of Acute Kidney Injury Per VARC-3
Time Frame: 30 days post procedure
Secondary safety endpoint, Rate of Acute Kidney Injury per VARC-3
30 days post procedure
Access-related Type 3-4 Bleeding Per VARC-3
Time Frame: 30 days post procedure
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
Time Frame: 30 days post procedure
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
Time Frame: 30 days post procedure
Secondary effectiveness endpoint, Rate of freedom from coronary artery ostia obstruction related to the intervened leaflet
30 days post procedure
Shortcut Technical Success
Time Frame: At exit from procedure room, immediately after the procedure
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of All Cause Mortality Per VARC-3
Time Frame: 90 days post procedure
Tertiary Safety Endpoint, Rate of all cause mortality per VARC-3
90 days post procedure
Rate of Stroke Per VARC-3
Time Frame: 90 days post procedure
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
Time Frame: 90 days post procedure
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pi-cardia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hadas Givon, Pi-cardia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 3, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 12, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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