Aortic Valve Stenosis
Conditions
Brief summary
The study objective is to evaluate safety and effectiveness/performance of the Microport™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis in the real world settings.
Detailed description
This is a prospective, single-arm, multi-center, observational, post-market registry study. The purpose is to evaluate the safety, performance, and effectiveness of the VitaFlow™ Transcatheter Aortic Valve System in the real world settings.Patients will be seen at pre and post procedure, discharge, 30 days, 1 year and annually up to 5 years.
Interventions
VitaFlow™ Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System,loading tools, a balloon dilatation catheter, and an introducer set
Sponsors
Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age≥70 years; * Symptomatic , calcified, severe, degenerative, native aortic valve stenosis : peak velocity ≥4.0m/s, or mean transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or aortic valve area\<0.8cm² (or EOA index\<0.5cm²/m²); * The patients considered to be not suitable for surgical aortic valve replacement (SAVR); * The patient has been informed of the nature of the study, is willing to enroll in the study by signing a patient informed consent and agreeing to the scheduled follow up requirement.
Exclusion criteria
* Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve； * Vascular diseases or anatomical condition preventing the device access； * Previous implantation of mechanical or bioprosthesis valve in the aortic position； * Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements； * Ongoing sepsis, including active endocarditis； * Estimated Life expectancy\< 12 months； * Participating in another trial and the primary endpoint is not achieved. * Inability to comply with the clinical investigation follow-up or other requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of all-cause mortality at 12 months post implantation | 12 months post implantation | Rate of all-cause mortality including cardiovascular and non-cardiovascular death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Valve function-effective orifice area | at discharge, 30 days, 1 year and annually up to 5 years post implantation | Effective orifice area measured by transthoracic echocardiography (TTE)(in cm\^2) |
| Valve function-degree of prosthetic valve regurgitation | at discharge, 30 days, 1 year and annually up to 5 years post implantation | Degree of prosthetic valve regurgitation, including paravalvular leak and intravalvular regurgitation measured by transthoracic echocardiography (TTE) |
| Rate of safety events according to VARC2 | at immediate, 30 days, 1 year and annually up to 5 years post implantation | Rate of safety events according to VARC2 including all-cause mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, new permanent pacemaker implantation |
| Rate of other TAVI-related complications | at immediate, 30 days, 1 year and annually up to 5 years post implantation | Rate of other TAVI-related complications including conversion to open surgery, unplanned use of cardiopulmonary bypass, coronary obstruction, ventricular septal perforation, mitral valve apparatus damage or dysfunction, cardiac tamponade, endocarditis, valve thrombosis, valve mal-positioning, TAV-in-TAV, valve related dysfunction requiring repeat procedure (TAVI,SAVR,BAV) |
| Valve function-mean transvalvular gradient | at discharge, 30 days, 1 year and annually up to 5 years post implantation | Mean transvalvular gradient measured by transthoracic echocardiography (TTE)(in mmHg) |
| Rate of balloon pre-dilatation success | at immediate post implantation | Rate of balloon pre-dilatation success, assessed by the access, delivery, pre-dilatation and retrieval of the balloon catheter |
| Rate of balloon post-dilatation success | at immediate post implantation | Rate of balloon pre-dilatation success, assessed by the access, delivery, post-dilatation and retrieval of the balloon catheter |
| Rate of procedure success | at immediate post implantation | Rate of procedure success, assessed by the device success and peri-procedural complications |
| Rate of device success | at immediate post implantation | Rate of device success, assessed by the access, delivery, deployment and implantation of the device and the prosthetic valve function |
Countries
China
Contacts
Primary ContactZhujun Cai, PhD
Backup ContactJie Bi
Outcome results
None listed