Clinical trial NCT06535659: VitaFlow LIBERTY Europe
Official title: VitaFlow Liberty™ Transcatheter Aortic Valve System Post-market Clinical Follow-up Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Aortic Valve Stenosis
Keywords: Transcatheter aortic valve replacement
Lead sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic, severe calcified aortic stenosis who are at high surgical risk.

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.


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)

Primary outcomes:
measure: Composite rate of all-cause mortality and stroke with disability
timeFrame: 12 months post procedure
Secondary outcomes:
measure: Safety outcomes defined by VARC3
timeFrame: 30 days, 12 months, and 2-5 years post procedure
measure: Safety outcomes defined by VARC3
timeFrame: 30 days and 12 months post procedure
measure: Safety outcomes defined by VARC3
timeFrame: acute procedure (within 24 hours)
measure: Device success
timeFrame: 30 days post implantation
measure: Device early safety
timeFrame: 30 days post implantation
measure: Bioprosthesis haemodynamic function
timeFrame: Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation
measure: Bioprosthesis haemodynamic function
timeFrame: Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation
measure: Bioprosthesis haemodynamic function
timeFrame: Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation
measure: Bioprosthetic valve dysfunction
timeFrame: 12 months and 2-5 years post procedure
measure: Bioprosthetic valve dysfunction
timeFrame: 12 months and 2-5 years post procedure
measure: Bioprosthetic valve dysfunction
timeFrame: 12 months and 2-5 years post procedure
measure: NYHA Classification
timeFrame: From baseline to discharge (24 hours to 7 days), 30 days, 12 months and 2-5 years post procedure
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: Galway University Hospital
Study officials:
affiliation: Galway University Hospital
name: Darren Mylotte, MD
role: PRINCIPAL_INVESTIGATOR
References: