Study Results
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View full resultsBasic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2022-01-21
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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ShortCut™
ShortCut™
Splitting bioprosthetic aortic valve leaflets
Interventions
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ShortCut™
Splitting bioprosthetic aortic valve leaflets
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
100 Years
ALL
No
Sponsors
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Pi-cardia
INDUSTRY
Responsible Party
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Locations
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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 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
UPMC Pinnacle
Wormleysburg, Pennsylvania, United States
Baylor Scott & White, The Heart Hospital Plano
Plano, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
CHU de Bordeaux (Bordeaux University Hospital)
Bordeaux, , France
Institute Mutualiste Montsouris
Paris, , France
Clinique Pasteur
Toulouse, , France
German Heart Institute Berlin
Berlin, , Germany
University Hospital Hamburg
Hamburg, , Germany
Leipzig Heart Institute
Leipzig, , Germany
Sha'are Tzedek Medical Center
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Royal Sussex County Hospital
Brighton, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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S01-CLN-002
Identifier Type: -
Identifier Source: org_study_id
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