VitaFlow LIBERTY Europe: real-world use of a transcatheter aortic valve

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

This project will test the safety and performance of the VitaFlow Liberty transcatheter aortic valve in adults with severe, symptomatic aortic stenosis who are at high risk for open-heart surgery.

Quick facts

• Study type: Observational
• Enrollment: 122 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd. (Industry-sponsored)
• Locations: 6 sites (Galway and 5 other locations)
• Trial ID: NCT06535659 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm, multi-center observational post-market registry documenting the clinical safety and performance of the MicroPort CardioFlow VitaFlow Liberty transcatheter aortic valve system in routine practice for severe aortic stenosis. Enrolled patients receive the VitaFlow Liberty valve via transcatheter implantation and undergo screening, procedure, discharge, and scheduled follow-up visits per local standard of care. The primary endpoint is the composite rate of all-cause mortality and stroke with disability at 12 months, with additional collection of procedural outcomes and device performance measures. Study sites are located in Europe (Ireland, Italy, Spain) and data are collected to provide real-world evidence on device safety and effectiveness.

Who should consider this trial

Good fit: Adults (≥18 years) with severe, symptomatic calcific aortic stenosis who are considered high risk for surgical aortic valve replacement, can consent, and can comply with follow-up requirements are eligible.

Not a fit: Patients with a pre-existing mechanical aortic valve, active endocarditis or sepsis, known hypersensitivity to required materials or antithrombotic regimens, anatomical unsuitability for the device, left ventricular ejection fraction under 20%, or estimated life expectancy under 12 months are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, the registry could support broader use of the VitaFlow Liberty valve as a validated less-invasive treatment option for high-risk patients with severe aortic stenosis.

How similar studies have performed: Transcatheter aortic valve replacement (TAVR) as a treatment approach has extensive positive evidence in multiple trials, though device-specific real-world data for VitaFlow Liberty are more limited and this registry aims to add that evidence.

Eligibility criteria

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)

Where this trial is running

Galway and 5 other locations

• Galway University Hospital — Galway, Ireland (Not_yet_recruiting)
• Ospedale Cisanello — Pisa, Italy (Recruiting)
• Hospital Universitario de a Coruna — A Coruña, Spain (Recruiting)
• Hospital Clínico San Carlos — Madrid, Spain (Recruiting)
• Hospital clinico Universitario de Valladolid — Valladolid, Spain (Recruiting)
• Luzerner Kantonsspital | Herzzentrum — Lucerne, Switzerland (Recruiting)

Study contacts

• Principal investigator: Darren Mylotte, MD — Galway University Hospital
• Study coordinator: Luying Yan

Conditions Aortic Valve Stenosis; Transcatheter aortic valve replacement