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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm, treatment group | Subjects in the treatment group will be implanted with the VitaFlow™ Transcatheter Aortic Valve System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VitaFlow™ Transcatheter Aortic Valve System | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of all-cause mortality at 12 months post implantation | Rate of all-cause mortality including cardiovascular and non-cardiovascular death | 12 months post implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Valve function-mean transvalvular gradient | Mean transvalvular gradient measured by transthoracic echocardiography (TTE)(in mmHg) | at discharge, 30 days, 1 year and annually up to 5 years post implantation |
| Valve function-effective orifice area |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes symptomatic patients (≥70 years old ) with calcified, severe, degenerative, native aortic valve stenosis who are not suitable for the surgical aortic valve replacement as assessed by the heart team
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhujun Cai, PhD | Contact | (86)(21)38954600 | zjcai@micoport.com | |
| Jie Bi | Contact | (86)(21)38954600 | jbi@micoport.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijing Hospital,Jiaotong University School of Medicine | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Effective orifice area measured by transthoracic echocardiography (TTE)(in cm^2)
| at discharge, 30 days, 1 year and annually up to 5 years post implantation |
| Valve function-degree of prosthetic valve regurgitation | Degree of prosthetic valve regurgitation, including paravalvular leak and intravalvular regurgitation measured by transthoracic echocardiography (TTE) | at discharge, 30 days, 1 year and annually up to 5 years post implantation |
| Rate of safety events according to VARC2 | Rate of safety events according to VARC2 including all-cause mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, new permanent pacemaker implantation | at immediate, 30 days, 1 year and annually up to 5 years post implantation |
| Rate of other TAVI-related complications | 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) | at immediate, 30 days, 1 year and annually up to 5 years post implantation |
| Rate of device success | Rate of device success, assessed by the access, delivery, deployment and implantation of the device and the prosthetic valve function | at immediate post implantation |
| Rate of balloon pre-dilatation success | Rate of balloon pre-dilatation success, assessed by the access, delivery, pre-dilatation and retrieval of the balloon catheter | at immediate post implantation |
| Rate of balloon post-dilatation success | Rate of balloon pre-dilatation success, assessed by the access, delivery, post-dilatation and retrieval of the balloon catheter | at immediate post implantation |
| Rate of procedure success | Rate of procedure success, assessed by the device success and peri-procedural complications | at immediate post implantation |
| Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
|
| D014694 |
| Ventricular Outflow Obstruction |