VitaFlow LIBERTY Europe
NCT Number: NCT06535659
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Aortic Valve Stenosis
Interventions: DEVICE: VitaFlow Liberty™ Transcatheter Aortic Valve System
Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-12
Completion Date: 2032-06
Locations: Galway University Hospital, Galway, Ireland

Summary:
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.

Primary Outcome Measures: Composite rate of all-cause mortality and stroke with disability, Composite rate of all-cause mortality and stroke with disability, 12 months post procedure
Secondary Outcome Measures: 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., 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, 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, acute procedure (within 24 hours)|Device success, Device success defined by VARC 3, 30 days post implantation|Device early safety, Device early safety defined by VARC 3, 30 days post implantation|Bioprosthesis haemodynamic function, Bioprosthesis haemodynamic function (assessed by echocardiography) including effective orifice area (cm2)., 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)., 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)., 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, 12 months and 2-5 years post procedure|Bioprosthetic valve dysfunction, Bioprosthetic valve failure defined by VARC3, 12 months and 2-5 years post procedure|Bioprosthetic valve dysfunction, Clinically significant valve thrombosis defined by VARC3, 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, From baseline to discharge (24 hours to 7 days), 30 days, 12 months and 2-5 years post procedure