Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
122 participants
OBSERVATIONAL
2025-05-06
2032-06-30
Brief Summary
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Patients will receive transcatheter aortic valve replacement and examinations at the screening, procedure, discharge, and follow-up per local standard of care.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Single arm clinical investigation
VitaFlow Liberty™ Transcatheter Aortic Valve System
Transcatheter Aortic Valve Replacement with VitaFlow Liberty™ Transcatheter Aortic Valve System.
Patients will receive transcatheter aortic valve replacement and examinations at the screening, procedure, discharge, and follow-up per local standard of care.
Interventions
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VitaFlow Liberty™ Transcatheter Aortic Valve System
Transcatheter Aortic Valve Replacement with VitaFlow Liberty™ Transcatheter Aortic Valve System.
Patients will receive transcatheter aortic valve replacement and examinations at the screening, procedure, discharge, and follow-up per local standard of care.
Eligibility Criteria
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Inclusion Criteria
2. Subjects with severe, symptomatic, calcific aortic stenosis who are considered at high risk for surgical aortic valve replacement (AVR).
3. Subject can understand the purpose of the clinical investigation, has signed voluntarily the informed consent form and is agreeing to the scheduled follow up requirements.
Exclusion Criteria
2. A known hypersensitivity or contraindication to all anticoagulation /antiplatelet regimens (or inability to be anticoagulated for the index procedure), to nickel or titanium, to nitinol, to dairy products, to polyethylene terephthalate (PET) or contrast media
3. Ongoing sepsis, including active endocarditis
4. Anatomically not suitable for the VitaFlow Liberty TAV system
5. LVEF\<20%
6. Estimated life expectancy of less than 12 months
7. Any medical, social or psychological condition that in the opinion of the Heart Team precludes the subject from receiving transcatheter aortic valve replacement
8. Currently participating in another drug or device trial (excluding registries) for which the primary endpoint has not been assessed
9. Inability to comply with the clinical investigation follow-up or other clinical investigation requirements
10. Patients temporally unable to provide written informed consent (e. g. unconscious emergency patients)
18 Years
ALL
No
Sponsors
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Shanghai MicroPort CardioFlow Medtech Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Darren Mylotte, MD
Role: PRINCIPAL_INVESTIGATOR
Galway University Hospital
Locations
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Galway University Hospital
Galway, , Ireland
Ospedale Cisanello
Pisa, , Italy
Hospital Universitario de a Coruna
A Coruña, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital clinico Universitario de Valladolid
Valladolid, , Spain
Luzerner Kantonsspital | Herzzentrum
Lucerne, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Darren Mylotte, MD
Role: primary
Dr.Marco De Carlo
Role: primary
Dr Pablo Pinon
Role: primary
Dr.Luis Nombel
Role: primary
Dr. Filippo Pensotti
Role: primary
Dr.Stefan Toggweiler
Role: primary
Other Identifiers
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VitaFlow EU-2024
Identifier Type: -
Identifier Source: org_study_id