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.
Study Type
OBSERVATIONAL
Enrollment
122
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.
Galway University Hospital
Galway, Ireland
NOT_YET_RECRUITINGOspedale Cisanello
Pisa, Italy
RECRUITINGHospital Universitario de a Coruna
A Coruña, Spain
RECRUITINGComposite rate of all-cause mortality and stroke with disability
Composite rate of all-cause mortality and stroke with disability
Time frame: 12 months post procedure
Safety outcomes defined by VARC3
Rate of all-cause mortality, myocardial infarction, stroke, implanted related new and/or worsen conduction disturbances and arrhythmias, new permanent pacemaker implantation, procedure-related or valve-related hospitalization defined by VARC 3.
Time frame: 30 days, 12 months, and 2-5 years post procedure
Safety outcomes defined by VARC3
Rate of type 2-4 bleeding, major vascular and access-related complications, acute kidney injury (stage 2-4) defined by VARC 3
Time frame: 30 days and 12 months post procedure
Safety outcomes defined by VARC3
Rate of other acute procedural and technical valve related complications: conversion to surgery; unplanned use of mechanical circulatory support; implantation of multiple (\>1) transcatheter valves during the index hospitalization; valve mal-position
Time frame: acute procedure (within 24 hours)
Device success
Device success defined by VARC 3
Time frame: 30 days post implantation
Device early safety
Device early safety defined by VARC 3
Time frame: 30 days post implantation
Bioprosthesis haemodynamic function
Bioprosthesis haemodynamic function (assessed by echocardiography) including effective orifice area (cm2).
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Hospital Clínico San Carlos
Madrid, Spain
RECRUITINGHospital clinico Universitario de Valladolid
Valladolid, Spain
RECRUITINGLuzerner Kantonsspital | Herzzentrum
Lucerne, Switzerland
RECRUITINGTime frame: Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation
Bioprosthesis haemodynamic function
Bioprosthesis haemodynamic function (assessed by echocardiography) including mean transvalvular gradient (mmHg).
Time frame: Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation
Bioprosthesis haemodynamic function
Bioprosthesis haemodynamic function (assessed by echocardiography) including aortic regurgitation (paravalvular, central and total).
Time frame: Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation
Bioprosthetic valve dysfunction
Moderate or severe haemodynamic valve deterioration defined by VARC3
Time frame: 12 months and 2-5 years post procedure
Bioprosthetic valve dysfunction
Bioprosthetic valve failure defined by VARC3
Time frame: 12 months and 2-5 years post procedure
Bioprosthetic valve dysfunction
Clinically significant valve thrombosis defined by VARC3
Time frame: 12 months and 2-5 years post procedure
NYHA Classification
Changes in cardiac function at discharge, 30 days and 12 months and 2-5 years post implantation according to the NYHA Classification Scheme compared to baseline
Time frame: From baseline to discharge (24 hours to 7 days), 30 days, 12 months and 2-5 years post procedure