Clinical trial NCT04952909: The ShortCut™ Study Protocol
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) Procedure
Lead sponsor: Pi-cardia
Sponsor class: INDUSTRY
First posted: 2021-07-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: (Number of Patients With) ShortCut™ Device- and/or ShortCut™ Procedure-related Mortality and All Cause Stroke
timeFrame: Discharge or at 7 days post-procedure, whichever occurs first
measure: (Number of Patients With) Leaflet Splitting Success Using the ShortCut™ Device
timeFrame: Intra-procedure
Secondary outcomes:
measure: (Number of Patients With) All-cause Mortality
timeFrame: 30 days post procedure
measure: (Number of Patients With) All-cause Stroke
timeFrame: 30 days post procedure
measure: (Number of Patients With) Coronary Obstruction
timeFrame: 30 days post procedure
measure: (Number of Patients With) Myocardial Infarction With New Evidence of Coronary Artery Obstruction Requiring Intervention
timeFrame: 30 days post procedure
measure: (Number of Patients With) Major Vascular Complications
timeFrame: 30 days post procedure
measure: (Number of Patients With) Cardiac Tamponade
timeFrame: 30 days post procedure
measure: (Number of Patients With) Acute Kidney Injury
timeFrame: 30 days post procedure
measure: (Number of Patients With) Access-related Type 3-4 Bleeding
timeFrame: 30 days post procedure
measure: (Number of Patients With) Freedom From Coronary Artery Ostia Obstruction Related to the Intervened Leaflet
timeFrame: 30 days post index procedure
measure: (Number of Patients With) Freedom From Coronary Artery Intervention Related to the Intervened Leaflet
timeFrame: 30 days post index procedure
measure: (Number of Patients With) ShortCut™ Technical Success
timeFrame: At exit from procedure room
Other outcomes:
measure: (Number of Patients With) All-cause Mortality
timeFrame: 90 days post procedure
measure: (Number of Patients With) Stroke
timeFrame: 90 days post procedure
measure: (Number of Patients With) Myocardial Infarction With New Evidence of Coronary Artery Obstruction Requiring Intervention
timeFrame: 90 days post procedure
Locations:
city: Tucson
country: United States
facility: Tucson Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: Smidt Heart Institute Cedars-Sinai Medical
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente - San Francisco Medical Center
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Regional Medical Center
state: California
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center / Atrium Health
state: North Carolina
city: Wormleysburg
country: United States
facility: UPMC Pinnacle
state: Pennsylvania
city: Plano
country: United States
facility: Baylor Scott & White, The Heart Hospital Plano
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Bordeaux
country: France
facility: CHU de Bordeaux (Bordeaux University Hospital)
city: Paris
country: France
facility: Institute Mutualiste Montsouris
city: Toulouse
country: France
facility: Clinique Pasteur
city: Berlin
country: Germany
facility: German Heart Institute Berlin
city: Hamburg
country: Germany
facility: University Hospital Hamburg
city: Leipzig
country: Germany
facility: Leipzig Heart Institute
city: Jerusalem
country: Israel
facility: Sha'are Tzedek Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
Study officials:
References: