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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Galway University Hospital
  Galway, Ireland Recruiting
• Pineta Grande Hospital
  Castel Volturno, Italy Recruiting
• Ospedale Cisanello
  Pisa, Italy Recruiting
• Azienda Ospedaliera Regionale -S.Carlo
  Potenza, Italy Recruiting
• Hospital de Santa Cruz
  Carnaxide, Portugal Recruiting
• Hospital Universitario de a Coruna
  A Coruña, Spain Recruiting

Study contacts

• Principal investigator: Darren Mylotte, MD — Galway University Hospital
• Study coordinator: Yann Poezevara, PhD
• Email: Yann.Poezevara@cf.microport.com
• Phone: 0033-146013409

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring

  This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.

  Recruiting American College of Cardiology · Washington D.C., District of Columbia · NCT07908355

• Vericiguat to slow calcific aortic valve narrowing

  This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.

  Recruiting Phase 2 West China Hospital · Chengdu, Sichuan · NCT07715279

• CHATEAU Registry: Real-world outcomes after TAVR

  This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.

  Recruiting Eunpyeong St. Mary's Hospital · Seoul · NCT07709858

• Impact of TAVR on kidney function in people with aortic valve disease

  This registry tests how trans-catheter aortic valve implantation affects kidney function and the risk of kidney injury in adults with aortic stenosis.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma, RM · NCT07626710

• Hydra THV Transfemoral Valve Implantation in Severe Aortic Stenosis

  This registry tests how safely and effectively the Hydra THV works when implanted through the femoral artery in adults with severe symptomatic aortic stenosis.

  Recruiting at 8 sites Fundación EPIC · Aravaca and 7 other locations · NCT07566624

• How the type of sedation affects recovery after TAVR

  This study will test whether three common sedation approaches (propofol, dexmedetomidine, or midazolam with fentanyl) change how people recover on the first day after transfemoral TAVR.

  Recruiting Phase 4 Endeavor Health · Glenview, Illinois · NCT07556523

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.