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

Shanghai MicroPort CardioFlow Medtech Co., Ltd.6 sites in 4 countries122 target enrollmentMay 6, 2025

ConditionsAortic Valve Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Valve Stenosis
Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Enrollment: 122
Locations: 6
Primary Endpoint: Composite rate of all-cause mortality and stroke with disability
Status: Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 6, 2025

End Date

June 1, 2032

Last Updated

4 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Shanghai MicroPort CardioFlow Medtech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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
•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)

Outcomes

Primary Outcomes

Composite rate of all-cause mortality and stroke with disability

Time Frame: 12 months post procedure

Composite rate of all-cause mortality and stroke with disability

Secondary Outcomes

NYHA Classification(From baseline to discharge (24 hours to 7 days), 30 days, 12 months and 2-5 years post procedure)
Bioprosthesis haemodynamic function(Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation)
Device success(30 days post implantation)
Safety outcomes defined by VARC3(acute procedure (within 24 hours))
Device early safety(30 days post implantation)
Bioprosthetic valve dysfunction(12 months and 2-5 years post procedure)