The ShortCut™ Study Protocol

Not Applicable

Completed

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

• Registration Number: NCT04952909
• Lead Sponsor: Pi-cardia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-28
• Study First Submitted QC: 2021-06-28
• Study First Posted: 2021-07-07
• Study Start: 2022-01-21
• Status Verified: 2023-08
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31
• Results First Submitted: 2024-09-30
• Results First Submitted QC: 2025-01-30
• Last Update Submitted: 2025-01-30
• Results First Posted: 2025-02-03
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
(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	Intra-procedure	Assessed by echo and/or angiography

Secondary Outcome Measures

Name	Time	Method
(Number of Patients With) All-cause Mortality	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.
(Number of Patients With) All-cause Stroke	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.
(Number of Patients With) Coronary Obstruction	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.
(Number of Patients With) Myocardial Infarction With New Evidence of Coronary Artery Obstruction Requiring Intervention	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.
(Number of Patients With) Major Vascular Complications	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.
(Number of Patients With) Cardiac Tamponade	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.
(Number of Patients With) Acute Kidney Injury	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.
(Number of Patients With) Access-related Type 3-4 Bleeding	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
(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	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.

Trial Locations

Locations (23)

Tucson Medical Center; 🇺🇸 Tucson, Arizona, United States

Smidt Heart Institute Cedars-Sinai Medical; 🇺🇸 Los Angeles, California, United States

Kaiser Permanente - San Francisco Medical Center; 🇺🇸 San Francisco, California, United States

Los Robles Regional Medical Center; 🇺🇸 Thousand Oaks, California, United States

Medstar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Advocate Christ Medical Center; 🇺🇸 Oak Lawn, Illinois, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Morristown Medical Center; 🇺🇸 Morristown, New Jersey, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Carolinas Medical Center / Atrium Health; 🇺🇸 Charlotte, North Carolina, United States

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