VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial

Study Overview
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Brief Summary
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This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.

Detailed Description
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This a prospective, multi-center, single-arm, objective performance clinical investigation, aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis. A total of 145 subjects will be enrolled in 18 clinical centers within China. Clinical or telephone follow-up is scheduled at 30 days, 6 months, 12 months, and 2-5 years after valve implantation.

Official Title
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A Prospective, Multicenter, Single-arm, Objective Performance Clinical Investigation For Evaluation of the Safety and Effectiveness of MicroPort™ CardioFlow VitaFlow ™ II Transcatheter Aortic Valve System in the Treatment of Severe Aortic Valve Stenosis

Conditions
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Aortic Stenosis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥70 years; Symptomatic , severe, aortic valve stenosis : peak velocity ≥4.0m/s, or mean transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or effective orifice area<0.8cm² (or EOA index<0.5cm²/m²); NYHA≥II class; Estimated life-expectancy>12 months after implantation of the prosthetic valve; Anatomically suitable for the transcatheter aortic valve implantation procedure; The patients considered to high-risk or not suitable for surgical aortic valve replacement (SAVR), as assessed by two or above heart surgeons; 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: Acute myocardial infarction (MI) in last 30 days before the treatment; Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve； Complicated lesion of the aortic valve (aortic stenosis with severe regurgitation); moderate-severe mitral valve stenosis; severe mitral valve regurgitation; severe tricuspid valve regurgitation; Previous implantation of heart valve at any position； Hemodynamic instability requiring mechanical hemodynamic support devices; Need for emergency surgery for any reason; Hypertrophic cardiomyopathy with obstruction; Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%;Severe right ventricular dysfunction; Active peptic ulcer or upper gastro-intestinal bleeding within the past 3 months; Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements. Congenital aortic valve stenosis or unicuspid aortic valve; Vascular diseases or anatomical condition preventing the device access; Active endocarditis or other active infections at the time of treatment; 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm clinical investigation<br>Subjects in experimental group will be implanted with the VitaFlow™ II Transcatheter Aortic Valve System | Device: VitaFlow™ II Transcatheter Aortic Valve System<br>* VitaFlow™ II Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System, loading tools, and a guide-wire<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 prosthetic valve gradient | Mean prosthetic valve gradient measured by transthoracic echocardiography (TTE)(in mmHg) | at 30 days, 6 months, and 1 year post implantation | 
| Valve function- effective orifice area | Effective orifice area measured by transthoracic echocardiography (TTE)(in cm^2) | at 30 days, 6 months, and 1 year 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 30 days, 6 months, and 1 year 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, conduction disturbance and arrhythmias, and new permanent pacemaker implantation | at 30 days, 6 months, 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, and TAV-in-TAV | at 30 days, 6 months, 1 year and annually up to 5 years post implantation | 
| Rate of major adverse cardiac and cerebrovascular events(MACCE) | Rate of MACCE including all-cause mortality, stroke, myocardial infarction, re-intervention, arrhythmias, and conduction disturbances | at 30 days, 6 months, 1 year and annually up to 5 years post implantation | 
| Rate of device success | Rate of device success, assessed by death, the access, delivery, deployment and implantation of the device, prosthetic valve position and valve function | at immediate post implantation | 
| Rate of balloon pre-dilation success | Rate of balloon pre-dilation success, assessed by the access, delivery, pre-dilation and retrieval of the balloon catheter | at immediate post implantation | 
| Rate of balloon post-dilation success | Rate of balloon post-dilation success, assessed by the access, delivery, post-dilation and retrieval of the balloon catheter | at immediate post implantation | 
| Rate of procedure success | Rate of procedure success, assessed by the device success and the peri-procedural complications | at immediate post implantation |