Aortic Valve Stenosis
Conditions
Keywords
Transcatheter aortic valve replacement
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.
Interventions
DEVICEVitaFlow Liberty™ Transcatheter Aortic Valve System
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.
Sponsors
Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite rate of all-cause mortality and stroke with disability | 12 months post procedure | Composite rate of all-cause mortality and stroke with disability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device success | 30 days post implantation | Device success defined by VARC 3 |
| Device early safety | 30 days post implantation | Device early safety defined by VARC 3 |
| Safety outcomes defined by VARC3 | 30 days, 12 months, and 2-5 years post procedure | 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. |
| Bioprosthetic valve dysfunction | 12 months and 2-5 years post procedure | Moderate or severe haemodynamic valve deterioration defined by VARC3 |
| NYHA Classification | From baseline to discharge (24 hours to 7 days), 30 days, 12 months and 2-5 years post procedure | 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 |
| Bioprosthesis haemodynamic function | Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation | Bioprosthesis haemodynamic function (assessed by echocardiography) including effective orifice area (cm2). |
Countries
Ireland, Italy, Spain, Switzerland
Contacts
Primary ContactLuying Yan
Backup ContactZhujun Cai, PhD
Outcome results
None listed