VitaFlow LIBERTY Europe
- Conditions
- Aortic Valve Stenosis
- Interventions
- Device: VitaFlow Liberty™ Transcatheter Aortic Valve System
- Registration Number
- NCT06535659
- Lead Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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
- LVEF<20%
- Estimated life expectancy of less than 12 months
- Any medical, social or psychological condition that in the opinion of the Heart Team precludes the subject from receiving transcatheter aortic valve replacement
- Currently participating in another drug or device trial (excluding registries) for which the primary endpoint has not been assessed
- Inability to comply with the clinical investigation follow-up or other clinical investigation requirements
- Patients temporally unable to provide written informed consent (e. g. unconscious emergency patients)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Single arm clinical investigation VitaFlow Liberty™ Transcatheter Aortic Valve System -
- Primary Outcome Measures
Name Time Method Composite rate of all-cause mortality and stroke with disability 12 months post procedure Composite rate of all-cause mortality and stroke with disability
- Secondary Outcome Measures
Name Time Method NYHA Classification From baseline to discharge (24 hours to 7 days), 30 days, 12 months and 2-5 years post procedure 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
Bioprosthesis haemodynamic function Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation Bioprosthesis haemodynamic function (assessed by echocardiography) including aortic regurgitation (paravalvular, central and total).
Device success 30 days post implantation Device success defined by VARC 3
Safety outcomes defined by VARC3 acute procedure (within 24 hours) 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
Device early safety 30 days post implantation Device early safety defined by VARC 3
Bioprosthetic valve dysfunction 12 months and 2-5 years post procedure Clinically significant valve thrombosis defined by VARC3
Trial Locations
- Locations (1)
Galway University Hospital
🇮🇪Galway, Ireland