NCT06535659

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
74mo left

Started May 2025

Longer than P75 for all trials

Geographic Reach
4 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
May 2025Jun 2032

First Submitted

Initial submission to the registry

July 21, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

May 6, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2027

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2032

Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

July 21, 2024

Last Update Submit

December 19, 2025

Conditions

Aortic Valve Stenosis

Keywords

Transcatheter aortic valve replacement

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Safety outcomes defined by VARC3

    30 days, 12 months, and 2-5 years post procedure

  • Safety outcomes defined by VARC3

    30 days and 12 months post procedure

  • Safety outcomes defined by VARC3

    acute procedure (within 24 hours)

  • Device success

    30 days post implantation

  • Device early safety

    30 days post implantation

  • +7 more secondary outcomes

Study Arms (1)

Single arm clinical investigation

Device: VitaFlow Liberty™ Transcatheter Aortic Valve System

Interventions

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.

Single arm clinical investigation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

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

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Darren Mylotte, MD

    Galway University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luying Yan

CONTACT

86-010-66513642lyyan@microport.com

Zhujun Cai, PhD

CONTACT

86-021-38954600zjcai@microport.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2024

First Posted

August 2, 2024

Study Start

May 6, 2025

Primary Completion (Estimated)

June 6, 2027

Study Completion (Estimated)

June 1, 2032

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(3)IE(1)CH(1)IT(1)