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RECRUITINGOBSERVATIONAL

VitaFlow LIBERTY Europe

VitaFlow Liberty™ Transcatheter Aortic Valve System Post-market Clinical Follow-up Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a prospective, single-arm, multi-center, observational, post-market registry to document the clinical safety and performance of MicroPort CardioFlow VitaFlow Liberty™ Transcatheter Aortic Valve System in the routine practice for the treatment of severe aortic valve stenosis. The primary endpoint is the composite rate of all-cause mortality and stroke with disability at 12 months. Patients will receive transcatheter aortic valve replacement and examinations at the screening, procedure, discharge, and follow-up per local standard of care.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Subjects of age≥ 18 years 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 willing to sign a consent form form and is agreeing to the scheduled follow up requirements. Who Should NOT Join This Trial: 1. Pre-existing mechanical heart valve in aortic position 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 willing to sign a consent form (e. g. unconscious emergency patients) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Subjects of age≥ 18 years 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: 1. Pre-existing mechanical heart valve in aortic position 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)

Treatments Being Tested

DEVICE

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.

Locations (6)

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