Aortic Valve StenosisNCT06535659
VitaFlow LIBERTY Europe
An observational study of Aortic Valve Stenosis, run by Shanghai MicroPort CardioFlow Medtech Co., Ltd. at 9 sites in 5 countries.
Trial summary
This is a prospective, single-arm, multi-center, observational, post-market clinical investigation 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- VitaFlow Liberty™ Transcatheter Aortic Valve System
- Type of treatment
- Medical device
- How many people
- 222 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 6 May 2025to Jun 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic, severe calcified aortic stenosis who are at high surgical risk.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
9 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 5 countries
Italy3 sites, 3 recruiting
- Recruiting
Pineta Grande Hospital
Castel Volturno
Alberto Morello, +393397904191, albertomorello83@gmail.com
- Recruiting
Ospedale Cisanello
Pisa
Dr.Marco De Carlo, +39 050 971 9530, urp@ao-pisa.toscana.it
- Recruiting
Azienda Ospedaliera Regionale -S.Carlo
Potenza
Eugenio Stabile, +39 81 746 2228/53, eugeniostabile@gmail.com
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario de a Coruna
A Coruña
Dr Pablo Pinon, +34 981 17 80 00, info@jjphospitalaria.com
- Recruiting
Hospital Clínico San Carlos
Madrid
Dr.Luis Nombel, 91 330 30 00, gerent.hcsc@salud.madrid.org
- Recruiting
Hospital clinico Universitario de Valladolid
Valladolid
Dr. Filippo Pensotti, +34 983 42 00 00, ceim.asva@saludcastillayleon.esjalvarezgo
Ireland1 site, 1 recruiting
- Recruiting
Galway University Hospital
Galway
Darren Mylotte, MD
Portugal1 site, 1 recruiting
- Recruiting
Hospital de Santa Cruz
Carnaxide
Rui Teles, +351 21 043 1000, rcteles@outlook.com
Switzerland1 site, 1 recruiting
- Recruiting
Luzerner Kantonsspital | Herzzentrum
Lucerne
Dr.Stefan Toggweiler, 0412051111, ifo@luks.ch
About this study
Official title: VitaFlow Liberty™ Transcatheter Aortic Valve System Post-market Clinical Follow-up Study
This is a prospective, single-arm, multi-center, observational, post-market clinical investigation 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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- VitaFlow Liberty™ Transcatheter Aortic Valve System
- Keywords
- Transcatheter aortic valve replacement
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitaFlow Liberty™ Transcatheter Aortic Valve SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single arm clinical investigation | Not described Receives: Device: VitaFlow Liberty™ Transcatheter Aortic Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite rate of all-cause mortality and stroke with disability
Composite rate of all-cause mortality and stroke with disability
Measured: 12 months post procedure
Secondary outcomes (15)
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.
Measured: 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
Measured: 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
Measured: acute procedure (within 24 hours)
Device success
Device success defined by VARC 3
Measured: 30 days post implantation
Device early safety
Device early safety defined by VARC 3
Measured: 30 days post implantation
Bioprosthesis haemodynamic function
Bioprosthesis haemodynamic function (assessed by echocardiography) including effective orifice area (cm2).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 12 months and 2-5 years post procedure
Bioprosthetic valve dysfunction
Bioprosthetic valve failure defined by VARC3
Measured: 12 months and 2-5 years post procedure
Bioprosthetic valve dysfunction
Clinically significant valve thrombosis defined by VARC3
Measured: 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
Measured: From baseline to discharge (24 hours to 7 days), 30 days, 12 months and 2-5 years post procedure
Rate of Alwide Plus Balloon Catheter pre-dilation success
Defined as successful access, delivery and dilation the aortic valve, and retrieval for the AlwideTM Plus balloon catheter
Measured: During procedure
Alwide Plus Balloon Catheter related adverse-event
Measured: Discharge
Predictors for the permanent pacemaker implantation
Including but not limited to pre-existing conduction disturbance, implant depth, LVOT calcium volume , post-dilatation
Measured: Baseline or intraprocedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start6 May 2025
- Primary completion6 Jun 2028 (estimated)
- Study completionJun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Darren Mylotte, MD, Principal investigator, Galway University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535659
- Sponsor's protocol ID
- VitaFlow EU-2024
- Status last verified
- Dec 2025
- First submitted
- 21 Jul 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VitaFlow Liberty™ Transcatheter Aortic Valve System Post-market Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT06535659
- Acronym / sponsor ID
- VitaFlow EU-2024
- Conditions
- Aortic Valve Stenosis
- Keywords
- Transcatheter aortic valve replacement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 May 2025 (actual)
- Primary completion
- 6 Jun 2028 (estimated)
- Study completion
- Jun 2033 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single-arm, multi-center, observational, post-market clinical investigation 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm clinical investigation | – | Device: VitaFlow Liberty™ Transcatheter Aortic Valve System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic, severe calcified aortic stenosis who are at high surgical risk.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VitaFlow Liberty™ Transcatheter Aortic Valve SystemTranscatheter 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. | Device | Single arm clinical investigation |
Primary outcome
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
15 secondary outcomes
Safety outcomes defined by VARC3
Time frame: 30 days, 12 months, and 2-5 years post procedure
Safety outcomes defined by VARC3
Time frame: 30 days and 12 months post procedure
Safety outcomes defined by VARC3
Time frame: acute procedure (within 24 hours)
Device success
Time frame: 30 days post implantation
Device early safety
Time frame: 30 days post implantation
Bioprosthesis haemodynamic function
Time frame: Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation
Bioprosthesis haemodynamic function
Time frame: Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation
Bioprosthesis haemodynamic function
Time frame: Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation
Bioprosthetic valve dysfunction
Time frame: 12 months and 2-5 years post procedure
Bioprosthetic valve dysfunction
Time frame: 12 months and 2-5 years post procedure
Bioprosthetic valve dysfunction
Time frame: 12 months and 2-5 years post procedure
NYHA Classification
Time frame: From baseline to discharge (24 hours to 7 days), 30 days, 12 months and 2-5 years post procedure
Rate of Alwide Plus Balloon Catheter pre-dilation success
Time frame: During procedure
Alwide Plus Balloon Catheter related adverse-event
Time frame: Discharge
Predictors for the permanent pacemaker implantation
Time frame: Baseline or intraprocedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Darren Mylotte, MD principal investigator
Galway University Hospital
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Shanghai MicroPort CardioFlow Medtech Co., Ltd. at 9 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy, Spain, Ireland, Portugal, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yann Poezevara, PhD (0033-146013409, Yann.Poezevara@cf.microport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite rate of all-cause mortality and stroke with disability (time frame: 12 months post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.