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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
60
Splitting bioprosthetic aortic valve leaflets
Tucson Medical Center
Tucson, Arizona, United States
(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
(Number of Patients With) Leaflet Splitting Success Using the ShortCut™ Device
Assessed by echo and/or angiography
Time frame: Intra-procedure
(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.
Time frame: 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.
Time frame: 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.
Time frame: 30 days post procedure
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Smidt Heart Institute Cedars-Sinai Medical
Los Angeles, California, United States
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San Francisco, California, United States
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Thousand Oaks, California, United States
Medstar Washington Hospital Center
Washington D.C., 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
...and 13 more locations
(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.
Time frame: 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.
Time frame: 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.
Time frame: 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 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.
Time frame: 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
Time frame: 30 days post procedure
(Number of Patients With) Freedom From Coronary Artery Ostia Obstruction Related to the Intervened Leaflet
Time frame: 30 days post index procedure
(Number of Patients With) Freedom From Coronary Artery Intervention Related to the Intervened Leaflet
Time frame: 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.
Time frame: At exit from procedure room