VitaFlow LIBERTY Europe
ConditionAortic Valve Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai MicroPort CardioFlow Medtech Co., Ltd.
About this trial
This is a prospective, single-arm, multi-center, observational, post-market clinical investigation 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects of age≥ 18 years
Subjects with severe, symptomatic, calcific aortic stenosis who are considered at high risk for surgical aortic valve replacement (AVR).
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.
Disqualifiers
Pre-existing mechanical heart valve in aortic position
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
Ongoing sepsis, including active endocarditis
Anatomically not suitable for the VitaFlow Liberty TAV system
Trial population
Patients with symptomatic, severe calcified aortic stenosis who are at high surgical risk.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
VitaFlow Liberty™ Transcatheter Aortic Valve System
DeviceTranscatheter 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.
Treatment groups
222 Participants
are divided into 1 treatment groupGroup A: Single arm clinical investigation1 intervention
Trial outcomes
Primary outcomes
1
Composite rate of all-cause mortality and stroke with disability
Composite rate of all-cause mortality and stroke with disability
Time frame
12 months post procedureSecondary outcomes
1
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 procedure2
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 procedure3
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)4
Device success
Device success defined by VARC 3
Time frame
30 days post implantationSponsors and contacts
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Source ClinicalTrials.gov