VitaFlow LIBERTY Europe

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

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 Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: VitaFlow Liberty™ Transcatheter Aortic Valve System

• Study Type: Observational
• Enrollment (Estimated): 122

Contacts and Locations

• Study Contact: Name: Luying Yan; Phone Number: 86-010-66513642; Email: lyyan@microport.com
• Study Contact Backup: Name: Zhujun Cai, PhD; Phone Number: 86-021-38954600; Email: zjcai@microport.com

Study Locations

• Ireland
  • Galway, Ireland
    • Not yet recruiting
    • Galway University Hospital
    • Contact: Darren Mylotte, MD
• Italy
  • Pisa, Italy
    • Recruiting
    • Ospedale Cisanello
    • Contact: Dr.Marco De Carlo; Phone Number: +39 050 971 9530; Email: urp@ao-pisa.toscana.it
• Spain
  • A Coruña, Spain
    • Recruiting
    • Hospital Universitario de A Coruña
    • Contact: Dr Pablo Pinon; Phone Number: +34 981 17 80 00; Email: info@jjphospitalaria.com
  • Madrid, Spain
    • Recruiting
    • Hospital Clinico San Carlos
    • Contact: Dr.Luis Nombel; Phone Number: 91 330 30 00; Email: gerent.hcsc@salud.madrid.org
  • Valladolid, Spain
    • Recruiting
    • Hospital Clinico Universitario de Valladolid
    • Contact: Dr. Filippo Pensotti; Phone Number: +34 983 42 00 00; Email: ceim.asva@saludcastillayleon.esjalvarezgo
• Switzerland
  • Lucerne, Switzerland
    • Recruiting
    • Luzerner Kantonsspital | Herzzentrum
    • Contact: Dr.Stefan Toggweiler; Phone Number: 0412051111; Email: ifo@luks.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic, severe calcified aortic stenosis who are at high surgical risk.

Description

Inclusion Criteria:

1. Subjects of age≥ 18 years
2. Subjects with severe, symptomatic, calcific aortic stenosis who are considered at high risk for surgical aortic valve replacement (AVR).
3. 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:

1. Pre-existing mechanical heart valve in aortic position
2. 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
3. Ongoing sepsis, including active endocarditis
4. Anatomically not suitable for the VitaFlow Liberty TAV system
5. LVEF<20%
6. Estimated life expectancy of less than 12 months
7. Any medical, social or psychological condition that in the opinion of the Heart Team precludes the subject from receiving transcatheter aortic valve replacement
8. Currently participating in another drug or device trial (excluding registries) for which the primary endpoint has not been assessed
9. Inability to comply with the clinical investigation follow-up or other clinical investigation requirements
10. Patients temporally unable to provide written informed consent (e. g. unconscious emergency patients)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single arm clinical investigation	Device: VitaFlow Liberty™ Transcatheter Aortic Valve System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd.
• Investigators: Principal Investigator: Darren Mylotte, MD, Galway University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2025
• Primary Completion (Estimated): June 6, 2027
• Study Completion (Estimated): June 1, 2032

Study Registration Dates

• First Submitted: July 21, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Transcatheter aortic valve replacement
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: VitaFlow EU-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No