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Completed

NCT Number: NCT04952909

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 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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux (Bordeaux University Hospital), Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ShortCut™

Device

Splitting bioprosthetic aortic valve leaflets

Primary outcomes

  1. (Number of Patients With) ShortCut™ Device- and/or ShortCut™ Procedure-related Mortality and All Cause Stroke

    Time frame: Discharge or at 7 days post-procedure, whichever occurs first

  2. (Number of Patients With) Leaflet Splitting Success Using the ShortCut™ Device

    Time frame: Intra-procedure

    Assessed by echo and/or angiography

Secondary outcomes

  1. (Number of Patients With) All-cause Mortality

    Time frame: 30 days post procedure

    (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.

  2. (Number of Patients With) All-cause Stroke

    Time frame: 30 days post procedure

    (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.

  3. (Number of Patients With) Coronary Obstruction

    Time frame: 30 days post procedure

    (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.

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

    Time frame: 30 days post procedure

    (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.

  5. (Number of Patients With) Major Vascular Complications

    Time frame: 30 days post procedure

    (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.

  6. (Number of Patients With) Cardiac Tamponade

    Time frame: 30 days post procedure

    (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.

  7. (Number of Patients With) Acute Kidney Injury

    Time frame: 30 days post procedure

    (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 baseline
    • Serum 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.

  8. (Number of Patients With) Access-related Type 3-4 Bleeding

    Time frame: 30 days post procedure

    (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

  9. (Number of Patients With) Freedom From Coronary Artery Ostia Obstruction Related to the Intervened Leaflet

    Time frame: 30 days post index procedure

  10. (Number of Patients With) Freedom From Coronary Artery Intervention Related to the Intervened Leaflet

    Time frame: 30 days post index procedure

  11. (Number of Patients With) ShortCut™ Technical Success

    Time frame: At exit from procedure room

    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.

Other outcomes

  1. (Number of Patients With) All-cause Mortality

    Time frame: 90 days post procedure

    (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.

  2. (Number of Patients With) Stroke

    Time frame: 90 days post procedure

    (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.

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

    Time frame: 90 days post procedure

    (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.

Sponsors and collaborators

Lead sponsor

Pi-cardia

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2021
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.