VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Multi-center, Post-market Registry Study Evaluating Safety and Effectiveness of the Microport™CardioFlow VitaFlow™Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: VitaFlow™ Transcatheter Aortic Valve System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| single arm, treatment group<br>Subjects in the treatment group will be implanted with the VitaFlow™ Transcatheter Aortic Valve System | Device: VitaFlow™ Transcatheter Aortic Valve System<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |